Preparatory study for an Impact Assessment on a new instrument replacing Council Decision 2005/387/JHA on new psychoactive substances

Transcription

1 Ref. Ares(2012) /07/2012 Preparatory study for an Impact Assessment on a new instrument replacing Council Decision 2005/387/JHA on new psychoactive substances Final Report to DG Justice

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3 Preparatory study for an Impact Assessment on a new instrument replacing Council Decision 2005/387/JHA on new psychoactive substances Final Report to DG Justice A report submitted by GHK Date: 27 July 2012 Petra van Nierop GHK 5em Etage 146 Rue Royale Brussels B-1000 T +32 (0) F +32 (0) brussels@ghkint.com iii

4 Document control Document Title Preparatory study for an Impact Assessment on a new instrument replacing Council Decision 2005/387/JHA on new psychoactive substances Date 27 July 2012 iv

5 Contents 1 Introduction Aims of this study Overview of the study methodology and progress update Overview of the Study Methodology Outline of completed tasks as part of the study Structure of this report Problem definition and diagnosis Policy relevance of new psychoactive substances Quantifying the overall problem of new psychoactive substances Problems related to the market dynamics and use of new psychoactive substances Problems related to the differences in national approaches to new psychoactive substances Problems linked to the Council Decision and related drivers The baseline scenario Right to act and subsidiarity Policy objectives Elaboration of policy options Status Quo Discontinue the Council Decision Cluster 1: Preparing to allow (some) NPS on the market Cluster 2: Basic elements Cluster 3: Improving Early Warning System and Joint Report procedures Cluster 4: Research and analytical capacities on new psychoactive substances Cluster 5: Addressing new psychoactive substances individually or in a group Cluster 6: Temporary emergency measures Cluster 7: Final decision on a new psychoactive substance Cluster 8: Education and awareness-raising Assessment of the policy options Introduction Status Quo Discontinue the Council Decision Cluster 1: Preparing to allow (some) NPS on the market Cluster 2: Basic elements Cluster 3: Improving Early Warning System and Joint Report procedures Cluster 4: Research and analytical capacities on new psychoactive substances Cluster 5: Addressing new psychoactive substances individually or in a group Cluster 6: Temporary emergency measures Cluster 7: Final decision on a new psychoactive substance The above measures would not restrict the availability of new psychoactive substances for research and legitimate industrial uses Cluster 8: Education and awareness-raising Comparison of the options and considerations on possible preferred options Comparative analysis of the policy options Considerations on the package of policy options which could be included in the preferred policy options Annex 1 Mapping of related safety mechanisms in the EU Annex 2 Relationship between Council Decision 2005/387/JHA and other EU mechanisms v

6 Annex 3 The role of international instruments in monitoring and regulating new psychoactive substances Annex 4 Individual health risks of new psychoactive substances Annex 5 Public health risks of new psychoactive substances Annex 6 Nationality and background of respondents to the online national stakeholder survey Annex 7 Bibliography vi

7 1 Introduction This Final Report is the fourth deliverable of the preparatory study for an Impact Assessment on a new instrument replacing Council Decision 2005/387/JHA on new psychoactive substances, an assignment being undertaken by GHK, on behalf of DG Justice. This Final Report provides the complete results of the study, including the problem assessment, the baseline scenario, and a full elaboration of the policy options for tackling the issue of new psychoactive substances. This report also includes a full assessment of the preferred policy option. The report is based upon information collected through several data collection activities undertaken as part of the study. The report has also taken into account the results from the second expert seminar held in Brussels on 01 March This Final Report also takes into account comments from the final Inter Service Steering Group meeting held on 23 March 2012 and comments on the Draft Final Report provided by the Client (the Commission s DG Justice). In particular, the main purposes of this Final Report are to: Present the problem assessment and baseline scenario; Present the policy objectives; Outline the policy options which have been developed by the Commission with support from the study team, assess their individual impacts and effects and use the information to elaborate the preferred option. Present the assessment of the preferred policy options, its intervention logic and monitoring and evaluation criteria 1.1 Aims of this study The overall aim of the study is to facilitate the Commission s work related to the revision or replacement of the Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances. The study aims to provide the Commission with the necessary evidence base and the analytical underpinnings for preparing an impact assessment report which fully complies with the Commission guidelines on impact assessment Specifically, the study will: Diagnose and define the problem to be tackled, including an assessment of the existing national systems addressing the emergence of new psychoactive substances; Suggest a hierarchy of policy objectives (i.e. general, specific and operational objectives; Consider whether EU action is justified on the grounds of subsidiarity, necessity and EU added value; Identify and elaborate a range of policy options that could potentially be deployed to tackle the problem(s) and achieve the stated policy objectives; Develop an appropriate assessment criteria for analysing the impact of individual policy options and for selecting the preferred policy option; Present a detailed assessment of the impact of each policy option including direct and indirect impact, risks, potential benefits and trade-offs; Carry out a comparative assessment of the policy options, including a cost-benefits analysis. In the assessment, further considerations would also be given to proportionality and EU added value; Present an elaboration and assessment of the preferred policy option; and, Final Report 1

8 Devise the monitoring and evaluation criteria and mechanisms for the preferred policy option, where possible using indicators to monitor the progress being made towards the stated policy objectives. Final Report 2

9 2 Overview of the study methodology and progress update This section of the report provides an overview of the study methodology and summarises the work which has been undertaken throughout the course of the assignment. 2.1 Overview of the Study Methodology The following research methods were used to collect and analyse evidence for this study: Desk Research This involved an in-depth review and analysis of existing documentation and data which inter alia included: Official documents published by the EMCDDA (and Europol) relating to the functioning of the Council Decision, as well as Risk Assessments and Joint Reports which had been carried out under the mechanism; EU policy and legislation on relevant issues such as licit and illicit drugs, food safety, medicines, and chemicals legislation etc.; and Academic and grey literature. Findings from the literature review have been included in the relevant sections of the report. A full list of the documentary sources of evidence is provided in Annex 7 to this report Expert seminars Through the course of this study DG JUST organised two expert seminars on the "Revision of Council Decision 2005/387/JHA on new psychoactive substances", which consisted of discussions and brainstorming sessions on the key areas of the impact assessment study: The first expert seminar took place on 15 December 2011 and focused on the preliminary problem definition and elaboration of the policy options the study. These are presented respectively in section 3 and 5 in the report; and The second expert seminar took place on 1 March 2012 and focused on the preliminary assessment of the policy options, which has been finalised and is provided in section 6 in this report. The expert seminars were attended by a variety of stakeholders such as: EMCDDA, EMA, Europol, WHO, Commission officials from relevant DGs (e.g. JUST, HOME, SANCO, ENTR, INFSO etc.), and Member State experts representing the EWS (National Focal Points), national forensic institutes, law enforcement bodies, academics, health experts involved in national drugs legislation, prevention and drug treatment NGOs, as well as NGOs working in the field of policy and advocacy, and former policy makers. Discussion papers on the problem definition and elaboration of policy options prepared by the study team were circulated to the seminar participants in advance in order to facilitate the discussion. Prior to the expert seminars two persons from the study team also attended as observers to the EU Horizontal Drugs Group at the Council of Ministers on 4 th October The meeting focused on key issues and challenges regarding the emergence of new psychoactive substances and Member States responses to the phenomenon Stakeholder consultations A series of semi-structured interviews, four online surveys, and six case studies were carried out with a wide range of stakeholders in the study at EU, Member State and international level. These included the following: Personal and telephone interviews with European Commission and executive agencies officials, as well as European umbrella associations working in relevant fields; Final Report 3

10 EU level An online survey with National Focal Points (NFPs) from the Reitox network, and Europol National Units (ENUs); Telephone and face-to-face interviews (as part of six country case studies), or online surveys with relevant national authorities in Member States such as Ministries of Justice and Ministries of Health, law enforcement authorities (e.g. police, customs), public health institutes, NGOs working in the field of prevention or user/ young people support, forensic institutes, academics and other relevant organisations; An online user survey launched in the Member States consulted through the case studies, and in three languages (English, German, and Polish) 1 ; An online industry survey launched among industry representatives; and Telephone interviews with relevant international organisations and representatives from third countries. A total of 266 stakeholders have been consulted across all Member States, the EU and internationally. Details of the breakdown of the total number of interviews across all levels and the stakeholders consulted in the context of this study are provided in the overview Table 2.1 below. The findings from these interviews have been included in the relevant sections of the report. Table 2.1 Stakeholder consultations undertaken in the study Level of stakeholder consultation Types of stakeholders consulted DGs (e.g. HOME, SANCO, ENTR, RTD, TAXUD, MOVE) EU agencies (e.g. EMCDDA, EMA, Europol, EFSA, ECHA) EU associations (e.g. EURAD, EFPIA, UTRIP) NFPs (Reitox network) (responses from AT, BG, CR, CY, CZ, DE, DK, EE, EL, FI, FR, HU, IT, LT, LV, MT, NL, NO, PT, RO, SE, SK, TR, UK) 24 Total number of completed interviews Comments 1 declined (DG INFSO) 6 NFPs did not provide a response (BE, ES, IE, LU, PL, SI) ENUs (responses from BG, DK, FR) 3 24 ENUs did not provide a response (e.g. all MS except for BG, DK, and FR) Total number of completed EU interviews/ survey responses 42 1 Organisations in contact with users of NPS were asked to post the survey on their website. Organisation in Poland, Germany, Romania and Finland posted the user survey on their website. Final Report 4

11 MS level Level of stakeholder consultation Types of stakeholders consulted Total number of completed interviews Comments Up to three interviews per MS: National authorities (e.g. Ministries of Justice, or other law enforcement bodies such as police, and customs); Ministries of Health, or public health institutes; and NGOs or academics etc. 64 interviews/ online survey responses 2 In13 MS all three stakeholders participated in an interview/ online survey (e.g. BE, BG, CZ, EL, ES, FI, FR, HU, IT, LU, NL, SI, UK) In 9 MS (CY, DE, IE, LV, MT, PL, RO, SE, SK) two of the three stakeholders participated in an interview/ online survey 5 MS (AT, DK, EE, LI, PT) one of the stakeholders participated in an interview/ online survey Interviews with head shops including traders' associations (the latter were also consulted through an online survey) and a Trading Standards Institute 4 interviews (1 UK head shop, 1 UK Trading Standards Board, Irish Alternative Traders Association and wholesaler of NPS ) The majority of head shops contacted in CZ, DE, DK, ES, FR, HU, IT, NL and UK did not wish to participate in the study Case studies in 6 MS DE, FI, NL, PL, RO and UK Up to 5-6 interviews per MS: EWS correspondent; Forensic institutes; Customs officials; Youth/ user support organisations; and Law enforcement authority 24 face-to-face interviews/ average of 5 interviews per MS In DE, UK and FI the customs were consulted. This was not possible for the other three case studies as no relevant correspondent was identified 3 Online user survey was launched in the majority of case study countries (RO, PL, DE and FI). Relevant organisations in contact with users of NPS posted the survey on their website. The responses were directly received by GHK through the online survey tool. 128 user responses were received The survey analysis in this report is based on all the 128 user responses. Responses were received from 128 users in the following MS: PL (49), DE (34), RO (22), FI (13), UK (2), IE (2), (BE (1), BG (1), CZ (1), DK (1), GR (1), LT (1) Total number of completed MS interviews/ survey responses 220 International level International organisations (e.g. UNODC, INCB, WHO) 3 2 Respondents were given the choice to either provide a written response to questions via an online survey or to take part in a telephone interview to provide responses to the same questions. 3 This may also be because the customs does not play a large role in detecting, testing and confiscating NPS. Final Report 5

12 Level of stakeholder consultation Types of stakeholders consulted Total number of completed interviews Comments Third Countries (response received from NZ) 1 Unable to organise interviews with representatives from Australia, Canada and the US after multiple attempts Total number of completed international interviews/ survey responses 4 Total number of interviews/ survey responses completed in the study Expert panel A panel of independent experts provided expert input and critical feedback at key stages of the study. The panel comprised the following experts: Prof. Simon Gibbons, Professor of Phytochemistry at the School of Pharmacy at the University of London. Prof. Gibbons is a member of the UK Home Office Advisory Council on the Misuse of Drugs (ACMD) and Chairman of the Novel Psychoactive Substances Workgroup which reports to the ACMD; and Dr. Jan van Amsterdam, Senior Scientist at the National Institute for Public Health and the Environment (RIVM) in the Netherlands. Dr. van Amsterdam is an expert with over twenty years of experience in the area of public health and drugs. The panel convened twice in GHK s premises in London as follows: First, to critically review the problem diagnosis, its further elaboration and preliminary assessment prepared by the study team, and to fine-tune and elaborate the assessment criteria and initial policy options, as well as their likely impacts; and Second, to validate and finalise the assessment of policy options, and to help select the preferred policy option. Two discussion papers were prepared by the study team each time in order to facilitate the discussions during the internal expert panels. 2.2 Outline of completed tasks as part of the study Table 2.2 below provides an overview of each step undertaken across all seven key tasks in the study. 4 This figure is based on the sum of138 interviews/ online survey responses completed in the study and 128 user survey responses. Final Report 6

13 Table 2.2 Outline of tasks and steps involved in the study Task Progress Next steps Task 0 Inception Step 0.1: Set up and kick-off meeting Step 0.2: First round of exploratory interviews Step 0.3: Preliminary desk research Step 0.4: Outline of the methodology and work programme Meeting was held on 21 September 2011 in Brussels. Meeting of the EU Horizontal Drugs Group at the Council of Ministers in Brussels was attended by the study team on 4 October Initial desk research that was undertaken to identify key sources of information to inform the problem diagnosis and assessment was completed at the Inception phase. The study methodology and the work programme were agreed with the Commission at the Inception phase. Completed Completed Completed Completed Task 1 Problem assessment Step 1.1: Understanding the scale of the problem Step 1.2 Assessing the functioning of the Council Decision and its synergies with other international, EU and national instruments The understanding of the scale of the problem has been fully conceptualised and evaluated. The problem diagnosis and assessment is presented in section 3 of this report. The assessment of the functioning of the Council Decision and its synergies with other relevant instruments has been undertaken. The assessment has been fully incorporated to the problem diagnosis and assessment. Completed Completed Task 2 Development of baseline Step 2.1: Outline of the baseline scenario Step 2.2: Considerations on subsidiarity and proportionality Baseline scenario has been developed, and its assessment has been included in section 3.6 of this report. The report presents the analysis of subsidiarity and proportionality in section 3.7 of the report. It is noted that the text has been taken from the Commission s draft Impact Assessment. Completed Completed Task 3 Elaboration of policy objectives Step 3.1: To identify policy statements made to address problems identified Step 3.2: Definition of general, specific and operational policy objectives Step 3.3: Articulation of assessment criteria for the policy options Relevant policy statements have been identified though the literature review and stakeholder consultations undertaken in the study. The policy objectives are presented in section 4of this report. Preliminary policy objectives were included in the interim report. They have been further elaborated on the basis of research activities and the expert panels and seminars undertaken in the study. Policy objectives are presented in Section 4 of this report. The assessment criteria for the policy options were included in the interim report and were further developed and specified in the course of the study. The criteria have been used to assess the policy options in Completed Completed Completed Final Report 7

14 Task Progress Next steps Section 6 of this report. Task 4 Elaboration of policy options Step 4.1: Initial proposal for policy options Step 4.2: Revision and further elaboration of policy options An initial proposal for policy options was included in the inception report. These were further refined in subsequent discussion papers that were first circulated to the three experts part of the study team in advance of the first internal expert panel. On the basis of the internal expert panel meeting these were further elaborated and subsequently presented in the first expert seminar held in Brussels on 15 December An initial set of policy options were included in the inception report. These have been further refined on the basis of consultation with the Commission, two internal expert panels and two expert seminars held in Brussels on 15 December 2011 and 1 March The final set of policy options is presented in Section 5 of this report. Completed Completed Task 5 Assessment of the individual policy options Step 5.1: Screening the individual policy options Step 5.2: Assessment of the individual policy options The method of approach to screening the policy options was included in the inception report and subsequently elaborated in the interim report. The policy options have been screened against these criteria. A detailed analytical framework for assessing the individual policy options was included in the inception report and further elaborated in the interim report. The assessment of the individual policy options is presented in section 6 of this report. Completed Completed Task 6 Comparison of policy options Step 6.1 Comparing the policy options The comparison of policy options is presented in section 7 of this report including an overview table of the individual scores of policy options. Completed Task 7 Proposal of preferred option Step 7.1: Detailed description of the preferred option and its intervention logic Step 7.2: Assessment of proportionality and EU added value Step 7.3: Elaboration of monitoring and evaluation criteria The preferred policy option is elaborated in detail in section of this report. The assessment of proportionality and EU added value is elaborated in section 3.7. The elaboration of monitoring and evaluation criteria is elaborated in section and the intervention logic of the preferred policy option in section Completed Completed Completed 2.3 Structure of this report The remainder of this Draft Final Report is structured as follows: Section 3 Problem definition and diagnosis Section 4 Elaboration of policy objectives and Final Report 8

15 Section 5 Presentation of the policy options Section 6 Assessment of the policy options Section 7 Comparison of the policy options and elaboration of the preferred option Annexes1 to 7 Annex 8, comprising of detailed economic assessments, has been provided in Excel format in conjunction with the submission of the Final Report Final Report 9

16 3 Problem definition and diagnosis This section firstly provides a brief background regarding the policy relevance of new psychoactive substances (NPS). Secondly, a detailed description of the problem diagnosis and assessment of the problems regarding NPS are presented. Finally, an analysis is provided of how the situation is likely to evolve in the absence of EU level action, providing for the baseline scenario. 3.1 Policy relevance of new psychoactive substances This sub-section presents the policy relevance and challenges related to the emergence of new psychoactive substances. It reviews why new psychoactive substances require policyrelated action and what the main challenges in trying to control these substances might be. It also presents reasons for the policy challenge and the current EU actions which have been taken in order to tackle the issues raised by psychoactive substances The policy challenge of new psychoactive substances Whilst new psychoactive substances commonly referred to as designer drugs or legal highs first emerged in the 1980s as legal alternatives to amphetamines and MDMA 5, they have recently posed a significant challenge to traditional drug policy-making in the EU. Some of the major concerns raised by the emergence of new psychoactive substances, challenging the existence of traditional approaches (control measures) or the introduction of new policy responses are the following: The term new psychoactive substances is broad, and encompasses a variety of different kinds of substances (e.g. herbal highs, synthetic drugs, party pills or research chemicals). 6 The Council Decision 2005/387/JHA defines new psychoactive substances as new narcotic or psychotropic drugs in pure form or in a preparation, which have not been scheduled under the 1961 United Nations Single Convention on Narcotic Drugs or the 1971 United Nations Convention on Psychotropic Substances, which relate to end-products, as distinct from precursors. 7 Whilst the Council Decision provides for a legal definition, there are other terms such as designer drugs and legal highs which are commonly used in the area, even though they might be slightly different concepts. According to the working definitions of new drugs used by the EMCDDA 8, for example, designer drugs are typically manufactured from chemical precursors and intentionally designed to mimic the effects of controlled drugs by altering their chemical structure and thus circumventing controls, while legal highs is an umbrella term encompassing new psychoactive substances (chemicals) or products claiming to contain the former, specifically intended to mimic the effects of controlled drugs. In addition to the variety and complexities of the terms used in the area, therefore, the scope of what each of them entails appears to be multifaceted as well. Moreover, the regulation of the different types of substances often may not be captured in one single type of legislation. Consequently, tackling the subject at stake has automatically become more complex. Changing legal status of new psychoactive substances, the vast majority of which are unregulated in the EU and across Member States; 5 Early Warning System on psychoactive substances Operating Guidelines (2007). Available from: 6 Winstock, A. & Wilkins, C. (2011), legal highs. The challenge of new psychoactive substances, Series on Legislative Reform of Drug Policies Nr. 16, October 2011, Transnational Institute 7 COUNCIL DECISION 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances, 8 Working definitions on new drugs as used by the EMCDDA EWS Final Report 10

17 Changing availability of substances which have recently exhibited rapid growth on the drugs market, greatly facilitated by trade over the Internet or through 'head shops'; Variation in new psychoactive substances chemical structure, which exacerbates their proliferation on the market and potentially increases harm to consumers; Insufficient understanding of the harms and effects of new psychoactive substances, given that such drugs are largely new and uncontrolled. Therefore, the main policy challenges posed by new psychoactive substances are on the one hand, the need of prompt and flexible measures to respond in a manner which is proportionate to the rapid emergence, variety and complexity of the phenomenon, and on the other hand, a lack of sufficient knowledge and understanding about their essence, effects and possible harms Relevant EU legislation The Council Decision does not prevent Member States from maintaining or introducing measures to control new psychoactive substances on their territory. However, in accordance with internal market rules, Member States are obliged to notify the Commission of any draft technical regulation (i.e. a decision to control or limit availability through medicines legislation). A number of EU directives and regulations enable Member States to adopt such decisions. They include the following instruments 9. Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services This Directive concerns draft technical regulations relating to all products and to information society services. It requires Member States to report immediately to the Commission technical regulations that may impede the internal market for goods 10. When Member States seek to limit the marketing or use of a chemical substance on grounds of public health, or the protection of consumers or the environment, they "shall also communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate". Member States "shall postpone the adoption of a draft technical regulation for three months from the date of receipt by the Commission" unless they are obliged to introduced it immediately "for urgent reasons, occasioned by serious and unforeseeable circumstances relating to the protection of public health or safety, (.) also for public policy, notably the protection of minors". Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and its subsequent amendments, as well as Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to veterinary medicinal products, and its subsequent amendments The first Directive including its subsequent amendments lays down the definition of a medicinal product for human use. Article 1 of this Directive stipulates the meaning of a medicinal product as any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or which may be used in or administered to the latter either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a 9 This information is a direct extraction of pages 13 to 15 from the Commission Staff Working Paper on the functioning of the Council Decision: 10 Under Article 8 (1) of Directive 98/34/EC, Member States are obliged to notify the Commission any draft technical regulations, except where it merely transposes the full text of an international or European standard. The procedure of Directive 98/34/EC gives Commission and Member States the opportunity to examine such new regulations during the standstill periods in order to make sure that the drafts, while ensuring a high level of safety and security, will not create unnecessary obstacles to trade. Final Report 11

18 medical diagnosis. 11 Similarly, the second Directive including its subsequent amending acts lays down the definition of a medicinal product for veterinary purposes (Article 1). According to point 5 in the preamble to the Council Decision 2005/387/JHA, the new psychoactive substances covered by it may include medicinal products as defined in the above two Directives. However, according to point 8 in the preamble to the Decision, substances of established and acknowledged medical value are therefore excluded from control measures based on this Decision. New psychoactive substances which are used to manufacture a medicinal product which has been granted or is pending a marketing authorisation are also excluded from the scope of the Decision, based on Article 7 (3). Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC The Mutual Recognition Regulation lays down procedures relating to the application of certain national technical rules on products lawfully marketed in another Member State. The main aim is to make the mutual recognition principle fully operational. The Regulation applies to administrative decisions addressed to economic operators on the basis of technical rules in respect of any product lawfully marketed in another Member State. As regards psychoactive substances, the Mutual Recognition Regulation should apply in particular cases and on a case by case basis. In particular, when competent authorities of a Member State intend to adopt a decision that could prohibit the marketing of those substances lawfully marketed in another Member State on other than safety or health grounds, the Regulation should apply. This is the case, for example, when a psychoactive substance lawfully marketed in another Member State is denied for reasons based on technical rules (denomination, size, composition, etc.). Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety The RAPEX system, coordinated by the Commission, enables national authorities competent for product safety to exchange very quickly and efficiently information on risk assessment, dangerous products and national restrictive measures taken in respect of these products. In cases of serious risk to the health and safety of consumers in the various Member States, the Commission may decide, subject to strict conditions, to withdraw the product from the EU market for one year, following the comitology procedure (Article 13). Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety The Regulation prohibits the placing on the EU market of foods which are not safe. It also states that food business operators are responsible for the compliance of food with the requirements of food law within the business under their control and shall recall and withdraw from the market a food product which is not in compliance with the food safety requirements. The Regulation confers special powers to the European Commission for taking emergency measures when it is clear that a food or feed is likely to pose serious risks to human health, and that such a risk cannot be contained satisfactorily by means of measures taken by the Member States. The Commission adopts such emergency measures following the comitology procedure, or in extreme cases can adopt emergency measures on its own, to be confirmed by the Committee within ten days. These measures can include withdrawal from the market of the food/ feed in question, laying down of special conditions for the products concerned, or any other appropriate interim measures. Member States exchange information about the existence of any direct or indirect risk to human health 11 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use and amending directives, pdf Final Report 12

19 deriving from a food/ feed and introduce alerts through the RASFF (Rapid Alert System), which is managed by the Commission (Article 50). Some new psychoactive substances can be treated as food, since, subject to few exemptions, any substance meant to be, or reasonably expected to be ingested by humans can be considered as food and therefore subject to food safety legislation (Article 2). Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs The Directive sets out the horizontal rules for the information that must be indicated on the labelling of foods (inter alia name of the food, list of ingredients, net quantity, etc.) and requires that their labelling, presentation and advertising must not be such that could mislead consumers as to the characteristics of the food and, in particular, as to its nature, identity or composition. According to Regulation (EU) No 882/2004 and No 1782/2002, Member States are responsible for the enforcement of EU food law and verify, through organisation of official controls, that the relevant requirements are fulfilled by food business operators. In particular, the competent national authorities carry out evaluation of the misleading character of the food information and its presentation and can also impose sanctions in this respect. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, and Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods The Directive establishes harmonised rules for the labelling of food supplements and introduces specific rules on vitamin and mineral substances in food supplements. The Regulation enables for a procedure to follow, to ban, limit or subject to scrutiny substances others than vitamins or minerals that represent a potential risk to consumers (Article 8). Requests by Member States to initiate this procedure are published on the Commission s website 12. Article 8 of the Regulation also applies to food supplements. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency Within the framework of REACH, the most relevant provisions for the purpose of this study concern the restriction process. Under REACH, either a Member State or the European Chemicals Agency (the latter at the request of the Commission) carries out the assessment of the hazard and risk of substances on their own, in mixtures or articles, where it is considered that they pose a risk to human health or environment that is not adequately controlled and which needs to be addressed on a EU-wide basis. On this basis, and also taking into account the socio-economic consequences, a restriction report is prepared and submitted for review to the Committee for Risk Assessment and the Committee for Socioeconomic Analysis in the European Chemicals Agency. Following the receipt of the Committees opinions, the Commission decides under the comitology procedure whether it restricts the manufacture, use or placing on the market, either completely or under specific conditions. In implementing REACH, Member States have to lay down penalties that are effective, proportionate and dissuasive, as well as to maintain a system of official controls and other activities as appropriate to the circumstances. In light of any potential changes to the EU instrument regulating new psychoactive substances, it will be important to consider which EU legislation are the most relevant for the regulation of new psychoactive substances and any potential (future) interrelationship with the new EU instrument. Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004 introduces new provisions that clarify and stipulate the relationship between the EMA and EMCDDA. In any possible new legislation amending the Council Decision 12 Final Report 13

20 2005/387/JHA, it will be necessary to check for consistency of reference between the medicines legislation and any new legislation on NPS. In addition, Directive 98/34/EC on technical standards sometimes plays a role in whether national legislation controlling NPS (that may not be controlled elsewhere in the EU) can be implemented, as it allows the Commission to review whether national technical regulations may create unnecessary obstacles to trade. Dependent on the policy options, it may be necessary consider this legislation. Although the legislation described above in relation to food safety, chemical safety and general product safety holds less significance for the monitoring, risk assessment and control of NPS as it is infrequently the case that NPS are recognised by these safety mechanisms, and they cannot be used to regulate such substances, there may be value in acknowledging the potential complementarity of these systems with the Council Decision in light of any future provisions. These issues are also discussed in Section below. 3.2 Quantifying the overall problem of new psychoactive substances The level of use and consumption of NPS is difficult to measure. Survey respondents may not accurately report use or may not constitute a representative sample, market data on sales is difficult to obtain as the products are not labelled as NPS. There have also been no systematic attempts to measure the scale of the effects on individuals and the wider economic and social consequences of NPS. The characteristics of the effects and wider consequences are however well researched, though the introduction of NPS by their nature contributes to changes in these characteristics over time. In these circumstances, one approach to estimating the scale of the problem resulting from NPS is to consider that the problem is analogous to the problems that derive from alcohol and/or from illicit drugs. Alcohol, illicit drugs and NPS are all psychoactive and have the potential to pose harm, including through the health and wider socio economic costs that they generate. Albeit that there are wide variations between the effects and detrimental and harmful consequences between and within these broad categories The analogy between NPS and alcohol Considering the analogy between NPS and alcohol, reliable information is available on the use of alcohol, the scale of the market, the effects on individuals and estimates have been made of the costs to society of alcohol. There are several reasons why such an analogy could be appropriate. Firstly, both NPS and alcohol are psychoactive, to some extent NPS are consumed as a substitute and/or in combination with alcohol and as part of social activities. Consumers are willing to pay similar prices, though NPS may offer price advantages as the products are not normally sold as NPS and are not directly taxed (in part to reduce consumption) as alcohol is. Secondly, the patterns of usage have similarities. Both types of substances are used by particular audiences for mainly recreational purposes (although the use of alcohol use is much more prevalent than the use of NPS) whilst only a limited number of users are frequent, intensive and problem and dependent users. Thirdly, some effects on individuals are similar. Alcohol and NPS are considered pleasurable by users, they lead to impaired concentration and reaction times. Both are 'poisons', and have addictive properties. Fourthly, and most importantly for the purposes of impact assessment, the range of economic and social costs arising from use and dependency, including health costs and criminality are similar for alcohol and certain (mostly stimulant) NPS. There are also several important differences that augur against using the analogy: Firstly, NPS are used by a small population group, mainly younger adolescents, and available data suggests that there is a tendency for their use not to be prolonged. For many Final Report 14

21 NPS is associated with experimentation and a phase. Alcohol is widely used by a wide range of population groups and is normally prolonged during an individual s lifetime. Secondly, Alcohol is taken in part for its taste, it is marketed vigorously, many alcohol brands have cache, and its social use does not attract stigma. NPS use is not considered socially acceptable, users perceive it as illicit and covert. NPS products are labelled not fit for human consumption. Users, tend not to advertise their use of NPS outside their circle of fellow users. Thirdly, NPS are much more heterogeneous in their composition, risk potential and effects than alcohol. Fourthly, NPS that are available on the consumer market change frequently and hence their effects and the wider repercussions of their use might change. In contrast alcohol and alcohol use is well established The analogy between NPS and illicit drugs Considering the analogy with illicit drugs, some information is available on the use of illicit drugs, the scale of the market, the effects on individuals and estimates have been made of the costs to society of illicit drugs. The information is however less good than the information on alcohol because of the illicit nature of activity. There are several reasons why such an analogy is appropriate. Firstly, a considerable number of NPS tend to mimic the effects of existing, popular illicit drugs such as cocaine, cannabis and ecstasy (MDMA). The main families of psychoactive substances notified in the EWS are cathinones, synthetic cannabinoids and phenethylamines. Secondly, NPS are used by a small population group, mainly younger adolescents, and there is a tendency for their use not to be prolonged. For many individuals, NPS is associated with experimentation and a phase. Both tendencies are pertinent, though less so, for illicit drugs. Thirdly, illicit drugs and NPS may be used in combination and to some extent the supply channels may overlap. Fourthly, both illicit drugs and NPS are both taken for their effects rather than tastes. There are also important differences that augur against using the analogy. In particular NPS are a relatively new phenomenon, and their characteristics are changing as new substances emerge, and hence their effects and the wider repercussions of their use are likely to change. In contrast illicit drugs are well established The specific analogy between NPS and Ecstasy for quantifying the market size and number of users There are parallels between NPS and ecstasy with regards to the user market and the age groups of users using these substances, which is why analogy to Ecstasy market in quantification of the NPS markets can be considered as appropriate. For example, the EMCDDA in its annual report for 2010 mentioned that practically all of the ecstasy users were between 15 and 34 years old. Several user surveys on NPS also show that the majority of NPS consumers also fall within this age group. In addition, the ecstasy market has also seen a rapid penetration in new psychoactive substances mimicking its effects, and therefore the ecstasy market is undergoing significant transformations particularly in Europe. Since about 2007 the amount of 'ecstasy' (MDMA) tablets available in Europe and the United Kingdom one of the largest markets has been declining while tablets sold as ecstasy increasingly containing greater proportions of substitute psychoactive substances not under international control, such as various piperazines like BZP, mcpp and TFMPP. For example, Final Report 15

22 in 2006 only 10% of tablets sold as ecstasy in the EU contained mcpp, but by the end of 2008 it was as high as 50% in some large-market countries 13. Using ecstasy as an analogy, it has been estimated that NPS represent a market value of 0.5 billion 14. This has been derived using the following assumptions: Market estimation: According to a Report on Global Illicit Drug Markets , the scale of Ecstasy market was estimated to be between 750 million and 6.2 billion (2005 prices). The low estimate of 750 million, which includes 20% of underreporting, has been used in the valuation of the overall market size, as adjusted to the prevalence of NPS use. Prevalence of use: The Eurobarometer (2011) on Youth Attitudes on drugs indicated that 5% of year olds had used legal substances that have similar effects to illicit drugs in their lifetime In analogy with Ecstasy, it has been assumed that last year prevalence of NPS use represents similar proportion among young aged as compared to that of Ecstasy in the age group. This analogy provides a prevalence estimate of 1.3% (last year use) for NPS 15 Considering that last year prevalence among young Ecstasy users aged was twice that of adult population aged 15-64, it is assumed that lifetime prevalence of NPS among the adult population is half of that of youth aged 15-24, i.e. 0.65% When adjusting the prevalence rate of ecstasy to that of NPS (i.e. 0.9% of ecstasy prevalence in 2005 and 0.65% prevalence for NPS as calculated above), the scale of the market for NPS is calculated as: In addition, using the above analogy for prevalence of use, it can be estimated that the number of last-year users of new psychoactive substances in the adult population is around 2.2 million 16. These estimates should be interpreted with caution for several reasons. The prevalence data from the Eurobarometer 2011 survey has limited statistical value, in particular if compared to more sophisticated and comparative methodologies used for the calculation of the prevalence of illicit drugs in Europe. The estimation compares different age groups of consumers, notably young adults users, of ecstasy (15-34 years old) and new psychoactive substances (15-24 years old). Furthermore, the data available for ecstasy and new psychoactive substances is collected in different years (2005, 2009 for ecstasy and 2011 for NPS). The country coverage is also slightly different because the Eurobarometer covers the 14 Please note that the logic follows the estimation undertaken by the Commission in the preliminary IA report. Much of the information used here has been derived from that report. 15 According to EMCDDA data (Annual report 2007), the lifetime prevalence of ecstasy in 2005 was 3% of EU adult population (15-64 years old) and the last-year prevalence was 0.9% (i.e. one third of the lifetime users). By 2009 lifetime prevalence of adult population increased to 3.2% while last-year use decreased to 0.7%. The lifetime prevalence among years-old Europeans was 5.5% and the last year prevalence 1.4% in 2009 (EMCDDA AR 2011). Accordingly, in analogy with ecstasy, it is assumed that last-year's prevalence of NPS use represents a similar proportion among young people aged as compared to that of ecstasy in the age group 15-34, i.e. 1.4% / 5.5% x 5% = 1.3%. 16 The most recent estimate of the EU-27 population is around 502,000,000 (Eurostat, March 2012). The adult population aged represents around 67% of this total, or million. As a consequence, the number of last-year users of new psychoactive substances in the adult population is estimated at 0.65% x = ± 2.2 million. Final Report 16

23 EU-27 while the illicit markets study does not cover Romania and Bulgaria. Finally, the estimate is a global calculation of the scale of the retail market and disregards differences in price and purity for ecstasy between countries, but also wide range of substances covered under the term 'new psychoactive substances', including price levels, purity and quantities consumed. Table below indicates the various sources that provide indications of the prevalence of use with respect to alcohol and illicit drugs to further contextualise the size of the NPS market. The most relevant data been incorporated in the calculations above. Table 3.1 Key data to inform estimate of the harm from drugs Characteristics Alcohol Illicit drugs (Heroin, Cocaine, cannabis, ecstasy) NPS Number/proportion of users in EU 85% of adult population (16 to 64 years of age); lifetime prevalence Source: EMCDDA, General Population Surveys (GPS) Cannabis:32% Cocaine: 5.9% Ecstasy: 5.5% Amphetamine: 5.0% Hallucinogenic mushrooms: 1-8% of young adults (15-34); lifetime prevalence 5% of young adults (15-24); lifetime prevalence Source: Eurobarometer, Youth attitudes on drugs (2011) Source: EMCDDA, General Population Surveys (GPS) and EMCDDA, Hallucinogenic Mushrooms: an emerging trend case study Problem users 23 million Europeans (5% of men, 1% of women, aged 15-64) are dependent on alcohol in any one year. Source: EMCDDA, General Population Surveys (GPS) Opioid and stimulant: 0.8% Opioid: 0.5% Stimulant: 0.4% Overall for all drugs: % of adult (15-64) population Source: EMCDDA, General Population Surveys (GPS) Scale of the EU market (euro) 11 litres pure alcohol per adult per year. EU aggregate household expenditure (2010) is billion Source: EC: Report: Alcohol in Europe, Ch. 4; and Eurostat, Annual National Accounts, Final consumption expenditure of households by consumption purpose Cannabis (retail market ): 13.5 billion ( a range from 6.1 billion billion) Heroin: 5 billion - 14 billion* Ecstasy: 750 million billion 17 Amphetamines: 1.1 billion 4.5 billion Cocaine (7 MS only 18 ): 9.5 billion (a range of 2.5 billion 24.5 billion) Source: A Report on Global Illicit Drugs Markets ; contract JLS/2007/C4/005 (2009) Heroin 22 billion Herbal cannabis : 38 billion Cannabis resin: 10 billion 17 Figure for EU27 18 FR, DE, IT, NL, PL, ES, UK. Final Report 17

24 Cocaine 23 billion Ecstasy 6 billion Amphetamine 9 billion Source: UNODC: World Drug Report Based on an estimate of the total global market value of illicit drug, 428 billion USD in 2005, with Europe having a 33% share. Estimate of scale of harm Key trends Tangible costs of Alcohol to EU25 society in bn euro (1.3%GDP) similar to tobacco. Intangible costs much greater Of the above: Crime: 33 billion (26%) Mortality: 36 billion (29%) Health/treatment: 22 billion (18%): Absenteeism: 9 billion (7%): Unemployment: 14 billion (11%) Source: EC: Report: Alcohol in Europe, Ch. 3 Reductions in use overall, problem use continuing Source: EC: Report: Alcohol in Europe, Ch. 4 The UK (Home Office) study, undertaken in 2000 on the economic and social costs of Class A drug use in England and Wales provides an estimate of the costs of harm per type of drug user. For the purpose of the study, the costs related to harm by young recreational users (i.e. who are not problem users) are highly relevant for estimating the harm to NPS users. Key findings used from the study: Young recreational users are at risk from toxicity and overdose which exceptionally lead to death. In 2000, 20 ecstasy related deaths were reported. The total social cost of each death was estimated at 1,144,890 in On the basis of the above deaths and other health services provided (toxicity, overdosing), health-related costs and other social costs were considered to average 60 per user. There is evidence of some causal association between productivity loss and recreational drug use but no data are available to estimate these effects There is no evidence of impact on unemployment There is no evidence of a causal relationship between acquisitive crime and younger recreational drug use, apart from acquisition / possession. The costs of a drug possession arrest valued at 1,346. Heroin: A decrease in the number of users of a range of 7%-17% from 2007 to Cannabis: A significant decline of about 30% between 2003 and 2008 or about 6% per annum. Use increasing and products changing rapidly Final Report 18

25 Cocaine: An increase in the number of users of a range of 5%-9% from 2007 to 2008/2009. Ecstasy and amphetamine: Stable/no change Hallucinogenic substances: Lifetime prevalence increased between 2003 and 2004 and the use also increased significantly from 2.4% in 2002 to 18 % in Source: Overall analysis undertaken in this impact assessment Source: UNODC: 2010 World Drug Report and EMCDDA, Hallucinogenic Mushrooms: an emerging trend case study Estimates of the scale of harm The principal purpose of the policy options being considered is to reduce the current and potential levels of harm arising from the availability and use of NPS. Considering the analogies set out above, it is considered that the best substance to compare NPS with in order to calculate the potential level of harm would again be ecstasy. On the basis of available evidence, NPS have led to some deaths (in particular mephedrone) which are comparable with the number of ecstasy-related deaths and there is little evidence that they cause other harms, related to unemployment and productivity loss, although these cannot be excluded. As indicated in the above table, the UK Home Office Study estimated that for recreational users, the group associated with new psychoactive substances, an average direct healthrelated cost 19 per user of 60 (at 2000 price levels). Corrected for an average inflation of 2.25% per year, this equals 80 or 96 for current price levels. When applying this to the estimated total number of new psychoactive substances users in the EU (2.2 million users - last year prevalence), the EU health-related costs of new psychoactive substances could correspond to 211 million per year. 3.3 Problems related to the market dynamics and use of new psychoactive substances A rapidly developing and changing market The market for new psychoactive substances has changed dramatically during the last years, increasing in both size and complexity. This phenomenon has also made it difficult for the Council Decision to respond effectively, as further elaborated in sections 3.4 and 3.5 below. Between 2005 and 2011, more than 200 new psychoactive substances were notified through the EWS, and are now being monitored. Over this period, however, the rate at which new substances appear on the market has increased, with record numbers of new substances being reported in the last years (24 in 2009, 41 in 2010, 49 in 2011). In 2012, 14 substances have been reported by 28 February). 19 Including the costs of medical and ambulance costs, human costs (death) and loss of outputs Final Report 19

26 Figure 3.1 Number of substances notified to the EWS Number of substances notified to the EWS The increase in the number of notifications illustrates both the rapid rise in the number of substances available in the EU, but also the improved reporting capacities in some Member States, which proactively search for new substances available on the market through controlled test purchases on the internet and from specialised shops. Between 2005 and 2011, five countries accounted for 75 % of all first notifications, with the United Kingdom reporting one third of new NPS to the EWS. However, it must be noted that many of these reported new psychoactive substances do not settle themselves in the market as a drug in their own right. In many cases it concerns chemically similar substances that are part of mixtures or that replace substances that have been brought under drug control. The market for new psychoactive substances has developed in different ways in the Member States. While the United Kingdom, Ireland, Poland, Finland and Romania have experienced an important increase in the availability of these substances, others, like France, the Netherlands and the Czech Republic, appear to have been much less affected. Moreover, while some new psychoactive substances tend to remain a national phenomenon and/or to rapidly disappear from the market, others, like mephedrone, gain EU-wide popularity. The reasons differ per substance and per country. Studies suggest that mephedrone had a specific appeal to users because of its price, quality and effects. Reports from the Netherlands indicate that mephedrone was popular throughout 2008, when there was a temporary shortage of MDMA in the market. When the shortage was over, mephedrone practically disappeared. Products such as "Spice", including synthetic cannabinoids chemicals which are functionally similar to THC, the active component in cannabis have emerged on the market in several countries (e.g. Germany, Austria). However, since controls were put in place in both Member States, the use of "Spice" seems to have dropped considerable, as users seem to have moved back to using natural cannabis again. In the GHK online survey of users, 104 respondents (81% of total respondents) provided responses to an open question as to the type of legal high they had used and why. Some respondents reported that they used substances which imitated and in order to substitute - cannabis, whereas others had used stimulants (e.g. those advertised as part of the Energy 20 Six substances were entered into the EWS January to May 2005 under the former Joint Action. From the beginning of the entry into force of Council Decision 2005/387/JHA, eight substances were entered into the EWS. See Annual Report 2005 on the implementation of Council Decision 2005/387/JHA, Annex 1. Final Report 20

27 group in headshops and online shops) or hallucinogenics (e.g. cacti and mushrooms). At least 19 (18%) reported that they used a mix of substances e.g. one respondent reported that he had used 2C-i, 2C-e, 5-MeO-aMT, 5-MeO-Dipt, MiPT as well as nitrous oxide, DXM for experimentation. Some referred to incense (particularly amongst German respondents) or smoking mixtures and many referred to brand names. These ranged from nutmeg, and Maya, Monkey Goes Banana, King Kong and Jazz in Germany; through to Typhoon and Strongman in Poland; to Pure by magic, Ganja, Spice Diamond, Ninja and head shot in Romania. There was no evidence of a particular pattern of usage by country, although this may be due to the sample size 21. With regard to trends in the use of substances and the type of substances used, several reports include mentioning of a relation between increased media attention and increased use, for example regarding the popularity of mephedrone in the UK (see section ). Finally, some substances are self-limiting, because they have unexpected or side effects which users do not like. The potential number of new psychoactive substances that could emerge on the market is very large and may run into the thousands. It is however not unlimited, as there are only so many chemical structures available which have certain psychoactive effects and which mimic known (illicit) drugs. The number of chemical precursors related to these substances may be even larger, with many of them used for different legitimate purposes. The very large market potential of NPS constitutes a strong argument for an EU response which supports monitoring, research and prevention, with EU management and control for substances with a clear EU dimension in terms of use / effects Characteristics of new psychoactive substances The issue of new psychoactive substances is not an entirely new one. They are used in order to experience a psychoactive response, much like many other substances, such as alcohol, tobacco, cannabis, opiates and cocaine. Late 20 th century chemistry was advanced enough to produce a rapid flow of new psychoactive drugs that found their niches in recreational markets (e.g. ketamine and GHB). Alexander Shulgin, a prominent chemist in the development of new psychedelics in the United States, notes that there were only two such substances in 1900 (marijuana, mescalin), 20 by 1950 and over 200 by The demand for psychoactive substances is of all times and every day a large part of the general public in Europe is using a variety of substances, including licit (e.g. alcohol and tobacco), on prescription (e.g. benzodiazepines, Ritalin) and illicit (e.g. cannabis, cocaine, etc) ones. The pharmaceutical and food industries frequently develop new products which enhance performance (e.g. Viagra, caffeine based), food supplements (e.g. vitamins, minerals), support the losing weight and similar products and this development is according to some still in its infancy. New psychoactive substances (like illicit ones) may have a depressant, stimulant and/ or hallucinogen effect (of combinations thereof) and tend to mimic existing, popular illicit drugs such as Cannabis and Ecstasy (MDMA). Similarly to these substances, they can be natural substances, such as herbs, fungi or plants, some of which may be or used to be used in specific traditional, religious or cultural settings (within Europe or abroad). Many new psychoactive substances are synthetic and are variations within a specific group of chemicals, sometimes (very) similar to substances submitted to drug control at national level. There are many chemical similarities between legal highs and endogenous neurotransmitters in humans, specifically serotonin, norepinephrine and dopamine. Several classes of legal highs have been modelled on existing and controlled drugs of abuse, particularly from the phenylethylamine (amphetamine), cocaine, phencyclidine and tryptamine classes. This is principally driven by the fact that there is a market for substances responses were received from 12 member States, with 72% of them from Poland (38%), Germany (27%), Romania (17%) and Finland (10%). 22 P. Reuter, Options for Regulating New Psychoactive Drugs: A review of recent experiences and an analytic framework, Final Report 21

28 which produce similar effects to illicit substances whilst remaining (at least for a while) legal. Moroever, chemists can readily identify those compounds that fall outside of legislation and are therefore legal, and the routes to these compounds are easily accessible from the literature 23. A variety of substances are available in many Member States. Table 3.2 provides information on the sorts of products 24 available from websites in a sample of Member States. Table 3.2 Example of the variety and price-range of products in Member States 25 MS Categories of legal high available Number of products available Price range Most expensive product Cheapest product Other information FR aphrodisiac, herbs, energy, hallucinogens, kratom, relaxers, mushrooms Maybe more than (most are around 5 20 ) Peyote cactus a Mexican cactus said to be a natural source of the hallucinogen TCB LSA grains LSA (lysergic acid amide) is a psychedelic Website also sells herbs, extracts, teas etc which have no psychoactive effect, as well as vitamins and herbal remedies. IT Smart drugs, herbal blends, mushrooms, etc. Around (most are around 5 20 ) Santa-Maria plant. Some smoking blends such as ketama gold and dream leaf are also around 20 koru energy strip In addition to products/plants that could be classed as legal highs there are more than 100 products (seeds, plants, etc) for growing cannabis and mushrooms. Only 14 smart drugs are available. NL Psychedelic, magic mushrooms (growing kits), mood enhancers, energy, salvia Around (greater quantities of salvia are more) Salvia dutch orange psychedelic herb mix There is a large mix and variety of products, most costing around 10 UK Ethnobotanicals, party pills, herbal blend, snow blow (snuff) salvia, aphrodisiacs, aclass energy range, energy Around Herbal incenses (various) Guarana 23 S. Gibbons, ""Legal Highs novel and emerging psychoactive drugs: a chemical overview for the toxicologist", in: Clinical Toxicology, Vol. 50, p It is not clear from the website the extent to which these can be considered separate legal highs (for example two categories of product common to the websites consulted above are Salvia Divinorum and Kratom which would be considered legal highs in their own right, whereas other categories include smart drugs happy caps or categorisation by effect (energy, relaxing, etc) which could include a number of different substances). Indeed, identical psychoactive substances may be marketed online under different commercial names to make the range of products seem wider than they actually are (see results of national stakeholder online survey). 25 FR: ; IT: ; NL: UK: Final Report 22

29 Number of substances MS Categories of legal high available Number of products available Price range Most expensive product Cheapest product Other information pills, happy caps, kratom National stakeholders in most Member States report that a wide variety of products is available (AT, BE, BG, FI, FR, DE, HU, IE, IT, LU, NL, PL. RO, ES, SE, UK 26 ). A smaller variety is reported in other Member States (CY, CZ, DK, EE, GR, LV, LT, MT, SK, SI). Overall, the NPS appearing in the European market have historically belonged to a small number of chemical families, but in the past five years new substances from an expanding range of chemical families have been reported. Most of the 41 new psychoactive substances identified in 2010 are cathinones and synthetic cannabinoids. The latter have been found in popular products such as 'Spice', which is a mixture of herbal products and synthetic cannabinoids, with different composition across countries. Synthetic cathinones are, after the phenethylamines, the second-largest family monitored by the EWS 27. Figure 3.2 Main groups of new psychoactive substances notified to the EMCDDA via the Early Warning System (2005 to February 2012) Other substances Synthetic cannabinoids Cathinones Piperazines Tryptamines Phenethylamines Year of notification Source: EMCDDA Available information suggests that these products are manufactured in commercial laboratories mostly outside Europe, probably in Asia (particularly China and elsewhere in South-East Asia) and are relatively cheap (for instance in 2011 mephedrone was sold at between EUR 18 and 25 for one gram Organisation of the market for new psychoactive substances Information on the economic operators and the distribution network is still limited. However, feedback from some of these operators suggests that most companies in the sector functions like any other commercial businesses i.e. with business plans, marketing 26 Views are mixed in BG, IE, LU, and NL according to the survey responses. One of the four respondents in BG argued that there is a small variety available, as did 1 of the 2 respondents from IE, 1 of 2 from LU and 1 of 4 respondents from NL. 27 EMCDDA, 2011 Annual report on the state of the drugs problem in Europe, Final Report 23

30 strategies, logistical networks, etc. Industries and businesses in the EU are involved in the synthesis (i.e. manufacture), distribution and sale of NPS The NPS Supply Chain The market for new psychoactive substances appears to have a similar structure those of several other products on the market (e.g. chemicals and medicines) and involves various levels of legitimate economic operators this is illustrated further in the schematic overview in Figure 3.3. Figure 3.3 Schematic overview of the NPS Supply Chain New psychoactive substances are most commonly produced outside the EU and imported. Alternatively, their precursors are imported, again mostly from outside the EU, for synthesis in the EU. A single company may play multiple roles within the NPS industry carrying out both the manufacture i.e. the synthesis of raw materials purchased elsewhere as well as the distribution (and packaging) of end-products already synthesised from manufacturers before selling onto retailers 29. Synthetic substances are manufactured in a variety of production environments: small labs, medium labs, factories and large plants, including large companies producing other pharmaceutical and chemical products. Manufacturers are most often based in India and China, but also in the EU. The latter tend to be smaller-scale, with those in India and China producing larger volumes within bigger plants. According to an industry representative, these companies have good knowledge on what happens in the EU market and anticipate bans by producing alternatives. Companies in the EU then import from the companies in third countries (and likely (re-)package) to distribute onto private vendors in different markets across the EU. 29 See the response to the online survey of industry. Final Report 24

31 Raw materials for synthetic substances (i.e. chemical precursors) are generally also supplied by companies in China and India 30. This is partly driven by the fact that Chinese exporters are able to self-declare the products that they send and are often fraudulent in their declaration 31 and in part by the fact that the precursors are often entirely legitimate substances. According to the industry representative 32 many of the chemicals required to synthesise new psychoactive substances may be purchased from (legitimate) chemical companies in the U.S.A or China 33. Precursors may have uses other than for synthesis in psychoactive substances (hence their legitimate sale) for example, some companies in third countries sell the precursor 4-methylpropiophenone (4-MPP used in mephedrone) for use in the synthesis of fine chemicals, perfumes, pharmaceuticals, resins, drugs and specialty chemical synthesis 34. Naturally-occurring psychoactive substances such as plantbased substances (e.g. Salvia, Kratom, Betel Nut, Kava Kava), cactuses (e.g. Peyote), and mushrooms are imported from S. America and South-East Asia. Many chemical precursors can be bought online, e.g. as research chemicals; legitimate European companies import these substances into the EU and distribute them to EU-based manufacturers. For example, European companies can be found that synthesise substances simulating MDMA and ketamine. 35 However, there has been no systematic research carried out as to the proportion of NPS manufacturers based in the EU as compared to third countries, nor is there much evidence to suggest that chemical precursors are produced in the EU 36. NPS may first be imported into Member States where there may be fewer restrictions on NPS and, from there distributed to others. The Dutch Public Prosecutors Office currently has a case involving a person who started a business selling legal highs in the Czech Republic, which expanded into Belgium and finally into the Netherlands 37. By contrast, a UK retailer interviewed for the purpose of this study stated that they only sell products that are bought from trusted suppliers that are UK-based. The courier / postal industries may (indirectly) play an important role in the import and distribution of NPS in some countries 38. According to representatives of customs in the UK, the majority of NPS come from overseas in small quantities, sent frequently, generally through air freight (FedEx, DHL, UPS, etc.) and post. Indeed, according to a study carried out in the UK 39 : The growth in the NPS market has brought a different type of drug dealer [...] Many people importing these new substances appear to have had no previous involvement in the illicit drug trade and are just in it to make a quick buck. They have included students who have set up websites to supply nationally and who also supply the local student population. 30 See Netherlands case study results and initial results of survey with industry (for results extracted ) 31 See UK case study results. 32 See the results of online survey of industry / consultation with industry representative (NL). 33 E.g Information provided in consultation with NPS industry representative. Websites in USA and China were accessed and confirmed that this substance was available and delivery was available to EU countries however, a warning was provided that orders would be reviewed before sending. Moreover, in registering to purchase the product, consumers are required to state the use of the product. This suggests that end-use is taken into consideration. 35 See e.g. - a UK-based website / British company manufacturing and selling MDME (an alternative to ecstasy) and MXE (an alternative to ketamine). See also the results of survey / consultation with industry. 36 However, in the absence of concrete data either way it is included in the supply chain diagram in Figure See Netherlands case study results. 38 See results of Finnish, Romanian and UK case studies 39 See Advisory Council on the Misuse of Drugs (ACMD) (2011) Consideration of the Novel Psychoactive Substances. Final Report 25

32 A large growth in the import / distribution of new psychoactive substances has also been identified in Finland where customs authorities are responsible for testing the substances for identification. According to these authorities the number of instances has grown in frequency from below 50 to over 1,000 in the past five years with most seizures weighing only 5-20g. One possible EU measure proposed by national stakeholders in Cyprus 40 and the UK 41 is to work closer with these industries. Particularly as, in some cases, substances imported in this way may include controlled as well as non-controlled substances. Available information shows that there is some involvement of organised crime in the market of new psychoactive substances. This involvement primarily takes the following forms Sale of new psychoactive substances (this due to their availability, popularity and cheaper wholesale price in comparison to illicit substances); Tableting and repackaging of certain NPS Sale of licit new psychoactive substances disguised as illicit drugs 42 ; and Sale of popular NPS (e.g. mephedrone) once they are subjected to control measures and criminal sanctions (where a market still remains) and legitimate sale can no longer be legally pursued. In the GHK online survey of national stakeholders (law enforcement, health authorities, NGOs and academics), over a third (37%) of the 64 national stakeholders consulted reported that a certain portion of NPS are sold through drug sellers dealing also in illicit substances this covered most responding countries (BE, CY, DK, EE, FI, DE, HU, IE, IT, LV, LT, NL, PL, RO, SI, UK 43 ). Indeed, as part of the same survey, stakeholders in nine Member States (AT, BE, CZ, EE, HU, LV, RO, SK, SI, UK) reported some involvement of criminal organisations in the import, production, distribution, and/or sale of NPS. 44 Bulgaria reported that organised crime is involved in the marketing of NPS to a large extent, and that this involvement has increased since May 2010 (according to Bulgarian customs). Romania also reported that organised crime involvement has increased in the past years, due to the profits generated by these activities and the rapid market emergence of new psychoactive substances. It is not clear what the actual level of involvement of organised crime is. According to Romanian law enforcement authorities, some illegal drugs dealer switched to selling legal highs due to stronger controls and higher prices on illicit substances such as cocaine and heroin 45. This may suggest a correlation between drug policies in certain Member States and the market in new psychoactive substances. The risk assessment on mephedrone 46 showed that OCG were involved to a limited extent, mostly for tableting. In the case of 4-MTA, which was submitted to control measures in 1999, there was evidence of large scale production and the involvement of organised crime 47. On the other hand, the risk assessment of BZP affirms that, apart from the large seizures, there was no other indication that pointed to the involvement of organised crime in 40 See National Stakeholder Survey 41 See UK Case Study. 42 Legal highs " on the net-evaluation of UK-based Websites, products and product information Schmidt, M. Sharma A, Schifano F, Feinmann C.(2011). Forensic Science International (2011) Vol. 206, Issue: See Annex 6 for further information on the background of the respondents. 44 AT, BE, CZ, LV, RO and UK reported some involvement of criminal organisations; EE, SK and SI reported very small involvement. HU reports that the involvement of organised crime is one of the main problems associated with legal highs in the Member State. None of these respondents provided evidence to support their statements, however. 45 See Romanian Case Study 46 EMCDDA Europol, Joint Report on a new psychoactive substance: 4-methylmethcathinone (mephedrone), The Evaluation Partnership Limited (2002), Assessment of the joint action on new synthetic drugs 16th June 1997 Final Report 26

33 the business 48 ; concerning "Spice"-like products, there is a lack of reports of criminality associated with the phenomenon 49. By contrast, there is strong evidence to demonstrate that OCG are cutting illicit substances with NPS to increase profitability or due to a scarcity of raw materials 50 needed to make the illicit substance, or are re-packaging NPS as illicit substances. Analysis of ecstasy tablets in Europe and beyond (e.g. New Zealand) over the last three years has shown them to contain substances other than, or in addition to, MDMA including caffeine, methamphetamine, piperazines and sometimes ketamine. 51 This was particularly the case in the Netherlands, in 2009, when the then legal new psychoactive substances MCCP and mephedrone were used by OCG to replace MDMA in the production of ecstasy tablets 52. Information on seizures also points at the potential involvement of OCG in the distribution and sale of some new psychoactive substances in combination with illicit drugs (forensic analysis of seized samples of new psychoactive substances in the UK indicated that 19% contained a controlled substance such as mephedrone and piperazines 53 ). Once a substance is submitted to control, it usually tends to reappear in the illicit one, where it is managed by criminal groups 54. For example, according to law enforcement authorities in Poland and the UK, since the introduction of control orders on mephedrone, it has become widely available on the illicit market. Evidence from the MixMag survey undertaken in 2011 suggests that, before the ban, in about 24% of cases mephedrone was obtained via dealers, whereas this increased to 58% after the ban. Producers and retailers of new psychoactive substances affirm that when a NPS is controlled, legitimate companies tend to step out of the market with organised crime becoming more active 55. However, in some cases NPS retailers may not respond less quickly. For example, in 2011 the UK s SOCA undertook the forensic analysis of seizures of NPS and indicated that 19% of samples also contained a controlled substance Size and value of the NPS industry Although some information is available on the dynamics of the European market for new psychoactive substances, there is little literature on its size and value. Estimates for the BZP market, which thrived in New Zealand in the mid-2000s suggest that the industry was worth million US$ (approx million euro) 57 per year with as many as 24 million BZP pills sold legally in the country by EMCDDA, Report on the risk assessment of BZP in the framework of the Council decision on new psychoactive substances, EMCDDA, 2010 Annual report on the state of the drugs problem in Europe, See, for example: European Monitoring Centre for Drugs and Drug Addiction (2009), The state of the drugs problem in Europe: Annual report 2009 (Lisbon: EMCDDA). Available at: 51 Winstock, A and C. Wilkins (2011) 'Legal Highs': the challlenge of new psychoactive substances. Transnational Institute Series on Legislative Reform of Drug Policies Nr. 16, October See Netherlands Case Study. This situation is also well-documented in the literature see, e.g. Van Laar, M. (2010), Drug abuse trends in the Netherlands. In Community Epidemiology Work Group (CEWG). U.S. Department of Health and Human Services. National Institute of Drug Abuse (NIDA) 53 ACMD, Consideration of the Novel Psychoactive Substances ( Legal Highs ). 54 J. Birdwell, J. Chapman and N. Singleton, Taking drug seriously A Demos and UK Drug Policy Commission report on legal highs, Consultation with industry. 56 ACMD, Consideration of the Novel Psychoactive Substances ( Legal Highs ). 57 Figure for June 2004, available at: 58 Sheridan, J., Butler. R., Wilkins. C. & Russell, B. (2007), Legal piperazine-containing party pills a new trend in substance misuse. Drug and Alcohol Review, 26(3): Available at: ; Gee, P. & Fountain, J. (16 February 2007), Party on? BZP party pills in New Zealand, New Zealand Medical Journal, 120(1249), Final Report 27

34 There are different reasons for this, including the fact that new psychoactive substances, or at least a large proportion of them, are not marketed as substances for human consumption and because the market is very heterogeneous and dynamic, including a fast-changing wide range of different substances (potentially thousands) with very different characteristics and effects. Most stay on the market only for a very short period, with only the popular ones having a longer duration it is estimated that from the 10 NPS which appear on the market each year, only 2-3 remain. Limited information obtained through the consultation of companies working in this market shows that annual turnover and profit can be large. For example, one company responding to a survey has an annual turnover of one million euro with a profit margin of 50% Marketing and sales of new psychoactive substances The new psychoactive substances industry is largely unregulated (except for in some Member States, e.g. Ireland and Poland see section 3.4) and sales are made primarily through specialised shops ( head shops / smart shops ) or online. Due to the lack of regulation, NPS are often marketed without correct or adequate labelling as to their content, effects, dosage / use Channels of the sale of NPS New psychoactive substances are marketed and sold through specialised shops, over the internet and, to a lesser extent, through sellers of controlled drugs. Figure 3.4 shows the main channels through which NPS are made available in Member States, according to national stakeholders. Figure 3.4 Channels through which new psychoactive substances are made available in the EU (by proportion of national stakeholders responding) (n=64) GHK online survey of National Stakeholders 1249/2422/ ; Cohen, B.Z.M. & Butler, R. (2 March 2011), BZP party pills: A review of research on benzylpiperazine as a recreational drug, International Journal of Drug Policy 22(2): , quoted in Winstock, A and C. Wilkins (2011) 'Legal Highs': the challlenge of new psychoactive substances. Transnational Institute Series on Legislative Reform of Drug Policies Nr. 16, October 2011 Final Report 28

35 Sales through the Internet An important part of the distribution and sales of NPS may take place via the Internet, although information on actual sales is not available. This is, in part, due to the fact that head shops are banned or restricted 59 in some Member States. The amount of websites in existence differs from Member State to Member State. In Italy, 120 Italian web sites selling legal highs were detected in the last 6 months of 2011 and in the UK more than 120 websites selling NPS were closed (again in 2011). By contrast, only 16 websites selling legal highs were identified in the Czech Republic in The importance of the internet in selling new psychoactive substances is increasing over time, although information on actual sales and market share of the total of purchased and/or used new psychoactive substances does not exist. The EMCDDA s 2011 internet snapshot survey of July identified 631 online shops selling new psychoactive substances/"legal highs" and shipping products to at least one EU Member State. This was twice the number of shops identified in January 2011 (314) and a more than three-fold increase since January 2010 (170). Around a third of the shops identified (197 of 631) were based in the United States of America, and a fifth were based in the UK. The factors between the rise in numbers of online shops are different to ascertain, but the may include an increase in online vending in response to growing demand or explansion resulting from the closure of physical smart shops (for instance, in Ireland, Poland and Romania). Online shops use predominantly English as an interface language (83% of online shops surveyed in 2011). Online shops have also introduced more sophisticated sales practices with more restrictive access measures to protect clients' and sellers' identities (e.g. using restricted websites). This is probably due to the fact that many of these online shops operate in uncertain environments where there is a continual risk that the products they sell will be or have been subjected to restrictions or control measures in certain countries, given the fact that such the lists of controlled substances can differ to a great extent between (EU) countries. As a result, shops also may publish a list of countries to which shipping is not possible 62, or encourage buyers to check the legal status of a product in their home country (sometimes linking to sites where this information is available). According to a survey carried out by the Commission in 2010, six Member States (IE, IT, PL, RO, ES, UK) have taken specific measures to tackle the sale of new psychoactive substances online while another eight Member States (EE, FI, FR, DE, LV, LT, PT, SE) use existing legislation for illicit drugs control, health or food and consumer protection to regulate online shops, responding to situations when they emerge 63. For example, the UK s Serious Organised Crime Agency (SOCA) worked with industry partners (e.g. ISP providers) to close down over 120 websites selling NPS in However, adversely, companies which had previously been selling in the UK via these websites merely moved their website elsewhere, i.e. to another jurisdiction Head shops and smart shops In certain countries (e.g. AT, BG, CZ, DE, HU, IT, LV, NL, SI, UK), so called "head shops" or smart shops are perceived to be main outlets for the sale of new psychoactive substances. 64 In some Member States head shops have been in existence for over a 59 Head shops are banned or restricted in Finland, Greece, Ireland and Romania. In addition, the following Member States have taken action to close down head shops in recent years: Poland, Slovak Republic and the United Kingdom. 60 Information provided through the survey with national stakeholders. 61 EMCDDA, Online sales of new psychoactive substances / 'legal highs': summary results from the 2011 multilingual snapshots, This can vary from product to product. In January 2010, 30 out of 170 online shops (18%) imposed restrictions on deliveries; this had risen to 253 out of 631 online shops (40%) in July SEC(2011) See national stakeholder online survey (GHK) Final Report 29

36 decade. For example, in the Netherlands, a report published in , already described on smart shops which sold "energizers", "relaxing herbs", "hallucogenic products" (e.g. "magic mushrooms") and "aphrodisiacs", as well as health products such as vitamins and minerals. The number of shops has declined considerably in recent years. In the Netherlands, where up to 60 head shops exist today, such shops were already reported at the end of the 1990s. The head shops in the Netherlands are mostly regulated through Municipal Ordinances. A few Member States have taken measures to counter the proliferation of "head shops". In Greece they are prohibited under anti-drug legislation Law 3459/06) 66. In Ireland, the number of head shops prior to the adoption of more stringent legislation in stood at over 100, but in October 2010, the number of open head shops had decreased to ten 68. In October 2010 the Polish authorities cracked down on about 1,200 head shops in the country 69. In response to the Polish crackdown at the beginning of 2011 tens of head shops opened in the Czech Republic, which had not existed there before. Head shops are also restricted in Finland. 70 In addition, the National Trade Inspectorate in the Slovak Republic 71 and authorities in the United Kingdom 72 have taken action to close down head shops in recent years. Following the introduction of legislation restricting the sale of NPS in Romania in 2011, the number of physical head shops decreased from 336 in 2010 to 91 in April A Romanian study suggests the majority of these moved their business to online sales 73. Similarly, in Latvia, the number of Internet shops and stores were reported to have decreased after certain NPS were subjected to control in Head shops are reported to not exist in Cyprus, Malta and Sweden. 75 However, in Cyprus, there are shops selling drug use paraphernalia (e.g. pipes) which also at one stage sold spice products; however, these were subsequently withdrawn when restrictions were introduced on their sale. In Hungary and Lithuania, the rules regulating the sale of food products apply to head shops, although, in Hungary, this is not considered to be effective. In Lithuania, the Food and veterinary agency, as well as the Inspectorate of non-food products and police may inspect and control such shops. In Netherlands, too, they are inspected by the Food and Consumer Product Safety Authority and head shop owners require a license from the local authorities. In Spain, 'grow shops', which sell products, may sell products traditionally available in head shops. The shops are regulated through an administrative licensing system. Similarly to Finland, in Estonia, the Medicinal Products Act, as well as general 65 National Institute of Public Health and the Environment, Smartshops Overzicht van producten, geclaimde werking en hun medisch-toxicologische relevantie, Overview of national responses to the Commission's survey of Council Decision 2005/387/JHA, provided to GHK by DG Justice. 67 The Misuse of Drugs Act 1977 (Controlled Drugs) (Declaration) Order 2010 put approximately 200 new psychoactive substances under criminal control, including synthetic cannabinoids, BZP and piperazine derivatives and a number of named cathinones. In the same year, Ireland adopted the Criminal Justice (Psychoactive Substances) Act 2010, which introduced a more general control by way of criminal justice legislation to deal with new psychoactive substances as they emerge. 68 National Advisory Committee on Drugs (NACD), An Overview of New Psychoactive Substances and the Outlets Supplying Them, See 70 See online national stakeholder survey. 71 See Overview of national responses to the Commission's survey of Council Decision 2005/387/JHA, kindly provided to GHK by DG Justice 72 See GHK UK Case Study 73 See Botescu, Andrei (2011) Research Report Evaluating new synthetic drug use - risks concerning children and youth in Romania. Funded by IrishAID and UNICEF Romania. 74 See Overview of national responses to the Commission's survey of Council Decision 2005/387/JHA, kindly provided to GHK by DG Justice 75 Ibid Final Report 30

37 marketing and consumer protection legislation, make it difficult for head shops to exist, although some of the products needed for cannabis plantation are available in so-called Indian shops. 76 In some Member States (e.g. Germany, Italy, Portugal), head shops are often not regulated 77. Information on how head shops may be monitored and regulated in the United Kingdom is provided in the Box 1 below. Box 1 Monitoring and regulation of head shops in the United Kingdom In the United Kingdom, other than consumer law and general product safety legislation, there is no regulation specific to head shops, although they could, to some extent, be regulated under the Unfair Trading Regulation of This law places an obligation on businesses to trade fairly, hence head shops they could be breaching this if they make false or deceptive statements or omit, hide or provide unclear information which the average consumer needs in order to make an informed decision, where (in either case) this causes the average consumer to take a different decision. This could be the case, for example, if a product is sold with a statement that it would be effective as plant food or bath salts (if they would not) and statements that products originated in the EU (if they did not). Compliance with Trading Standards is monitored through local authorities. Consumer complaints may trigger investigations of head shops and authorities may then visit the business concerned or carry out test purchases. If there are any national issues, issues within a specific industry or change in legislation trading standards may survey all the shops of a particular type within our area to ensure compliance. Some trading standards services also go on routine inspections and problems may be discovered this way Other forms of sale / distribution In some Member States NPS are made available in shops other than smart / head shops. In Germany it was reported that even regular shops such as filling stations, kiosks or video rental stores have been found to sell "legal highs" in isolated instances. A national stakeholder from Luxembourg reported that legal highs are sold there through sex shops. This was also the case with the sale of poppers in France. In Greece NPS have been sold in tobacco shops 79. As shown in Figure 3.4 above, NPS are also sold at parties or concerts or passed between friends. These findings confirm those of the 2011 Eurobarometer "Youth attitudes on drugs" 80 which found that NPS are mostly offered to young people by a friend (54% of those which had confirmed to have used such substances) or at a party or in a club (36%). Studies of the UK market also show that new psychoactive substances are purchased at music festivals 81 as well as through illicit drugs dealers. According to the MixMag survey undertaken in 2011, the control status of a substance may not affect whether users obtain it through friends or not: 38% of users stated that they obtained mephedrone through friends when it was legal, compared to 41% of users surveyed after the ban. 76 Ibid 77 Ibid 78 Information requested by GHK and provided in by a Lead Officer without Portfolio of the Trading Standards Institute, United Kingdom. 79 See also: Winstock, A and C. Wilkins (2011) 'Legal Highs': the challlenge of new psychoactive substances. Transnational Institute Series on Legislative Reform of Drug Policies Nr. 16, October European Commission, Flash Eurobarometer 330, Youth attitudes on drugs, M. Schmidt, A. Sharma, F. Schifano, C. Feinmann, ""Legal highs" on the net-evaluation of UK-based Websites, products and product information". Final Report 31

38 Labelling / marketing of NPS New psychoactive substances are not regulated and therefore do not undergo the normal stringent safety and quality control testing that is necessary in products that are for human consumption. In addition, they are regularly mislabelled or sold with no information regarding their chemistry, pharmacology or toxicology, no safety assessments and no administration instructions 82. These new substances are often advertised with aggressive marketing strategies and sometimes intentionally mislabelled with purported ingredients differing from the actual composition. A recent governmental study 83 in Ireland shows that most of the crucial product information for consumers is often not included in new psychoactive substance products and that this varies by the type of product. Of the 49 products tested, none of herbal products and 79% of powder products listed no ingredients, whereas 75% of tablet products and 67% of capsule products listed ingredients. Table 3.3 below shows a summary breakdown of the details supplied on the packaging of 49 products tested and Table 3.4 shows a breakdown of types of products that listed no information on the packaging. Table 3.3 Percentage of products (tablets, powders, capsules and herbal material) analysed that contained information on packaging, n=49 Type of information provided on packaging Percentage of total products with the information Ingredients 61 Health warnings 39 Dosage information 41 Expiry date 29 Contact details of the manufacturer 41 Not for human consumption 47 Source: NACD (2010) Table 3.4 Breakdown of the types of products that listed no information on the packaging No information Powders Tablets/capsules Herbal Ingredients (out of 19 samples) Health warnings (out of 30 samples) Dosage information (out of 29 samples) Expiry date (out of 35 samples) Contact details of manufacturer (out of 29 samples) 15 (79%) 2 (11%) 2 (11%) 20 (67%) 8 (27%) 2 (7%) 22 (76%) 5 (17%) 2 (7%) 20 (57%) 13 (37%) 2 (6%) 19 (66%) 8 (28%) 2 (7%) Source: NACD (2010) Similarly, according to a study on the UK online legal highs market in 2009, most products do not list ingredients or often (incorrectly) claim to contain several different herbs or plant extracts. Often the same substances are listed in different ways, either by active ingredients 82 ACMD (2011): 83 NACD (2010): Final Report 32

39 (e.g., ephedrine), traditional plant names (e.g., Ma huang) or botanical names (e.g., Ephedra sinica). In addition, different batches of the same legal high product may contain different active ingredients 84. Products also fail to list any side effects, contra-indications or potential interactions with other substances or medication. Those that do are of poor quality and include vague statements. This lack of safety information could lead to the erroneous assumption that legal highs are safe, especially amongst novice users. It has been shown that the belief that these substances are legal and therefore safe is one of the reasons for trying them 85. In some cases the mislabelling of products is intentional, and used to circumvent controls of the various types of legislation that may apply (drug law, product safety law, food law, medicine law). NPS are often marketed as plant food, bath salt, or research chemical. For example, mephedrone was variously advertised as a research chemical, bath salts, for botanical research, plant food or plant feeder, often with a note saying not for human consumption 86. UK authorities have noticed an increase in mislabelling following action to close down online stores. They report that more products are now labelled not for human consumption, as research chemicals or samples, or (mis-)labelled as an innocuous substance such as glucose 87. This was identified as a main issue of concern for self-reporting users of NPS. For example, one former user wrote: If I were to choose between getting fined by the police, or even going to jail, and screwing up my life because of some unknown substance, I [would] choose the first one. Indeed, lack of knowledge or imprecise knowledge about dosage, content and the associated health risks were perceived to be one of the main risks of consuming NPS (see Figure 3.11) (Other) sources of information Availability of and access to information on new psychoactive substances, their effects and possible harms is inconsistent across EU Member States. Due to a general lack of knowledge about the products consumed by users, the public have to rely on unofficial channels, such as online shops or user communities, to obtain information on the possible effects and risks of the products. In the Netherlands user forums 88 are accessed as a main source of information on legal highs, as the case in France, Sweden and the UK 89. In other Member States (e.g. CZ, EL, SK) social networks are an important channel of information, and in others (e.g. BG, CY, HU, UK) specialised NGOs, municipality drug councils, prevention and/ or harm reduction service providers also provide information on legal highs. The media may also be a source of (mis-)information on new psychoactive substances. In some cases, media hypes have indirectly resulted in control measures being based on anecdotal rather than scientific evidence. For example, the media coverage in the UK on mephedrone suggested that a killer drug had been introduced in the market, claiming many deaths and casualties. Whilst initially, tens of deaths were linked to the use of the substance, the subsequent EMCDDA Risk Assessment of mephedrone 90 found that only one of the deaths in the UK was directly linked to the misuse of the substance. Partially as a result of increased media attention, Member States such as Ireland, Poland and Romania have introduced strict control measures on legal highs, for example by closing smart and head shops. In some Member States media hypes have had the perverse effect of increasing curiosity / interest in the substances amongst young people, which may exacerbate their 84 Legal highs " on the net-evaluation of UK-based Websites, products and product information Schmidt, M. Sharma A, Schifano F, Feinmann C. (2011). Forensic Science International (2011) Vol. 206, Issue: Consideration of the Novel Psychoactive Substances ( Legal highs ), Advisory Council on the Misuse of Drugs, October EMCDDA Annual Report See UK Case Study 88 Such as and 89 See online national stakeholder survey 90 Final Report 33

40 use 91. In the Czech Republic media hype reportedly also led to an increase in the number of head shops Prevalence of use of new psychoactive substances Although little is known about the long-term prevalence of use of NPS across Europe, there is evidence to suggest that these substances have increased in demand, appeal and use, as demonstrated by the increase in the supply of such substances and the recent regulatory actions by Member States on such substances. Prevalence of use seems to be largely limited to specific groups such as young people (e.g. aged 15 to 30) and users of illicit substances however the profile of NPS users also varies from Member State to Member State. What is notable is that, in comparison with some illicit drugs (e.g. heroin) NPS users are often affluent, well-educated and having established social networks 93. According to the results of the GHK online survey of users, availability and legality may have increased the likelihood of use at least once, but there is some evidence to show that initial use of NPS may not lead to longer-term use, and that there is an element of experimentation / curiosity associated with use of NPS (see below). Obtaining reliable and comparable data on new psychoactive substances is complicated by a variety of methodological problems, including the variety of substances covered by the term, the fact that it is often unclear what people have actually taken because of mislabelling, the fact that user groups for a specific substance may be very small, etc. Moreover, there is currently no standardised approach to surveys on prevalence through EU27. Survey methodologies greatly from Member State to Member State and sometimes do not sufficiently take into account the fact that whereas some may use NPS regularly, others may try them only once, nor does it account for potentially higher prevalence rates amongst specific groups such as young people and illicit-drug users Overall prevalence of use It is difficult to count or to estimate the overall prevalence of use of NPS in the EU Member States given the lack of representative, cross-border studies on the prevalence of use. In the GHK survey of national stakeholders, respondents were asked to indicate the proportion of people who have used legal highs in their country in the last year (2011). Only 28 out of 64 respondents (44%) provided a response to the question 94. A further 16, - from BE, BG, FI, FR, GR, HU, IE, IT, SI, UK - stated that they were unable to provide an estimate. A further twenty respondents (one each from AT, BG, CY, CZ, EE, FI, GR, LV, LT, LU, MT, NL, PT, RO, SK, UK and two respondents from BE and from SI) provided no response at all to this question. Twenty respondents (71% of those responding) provided evidence for their estimate. In nine countries (BG, CZ 95, DE, HU, IE, LU, LV, PL 96, ES) the estimate was based on the findings from user surveys and in others it was based on analogy to the use of illicit substances (FR, SE), the extent to which treatment services and police have come across the substances (GR), or a market analysis (SE). However, four respondents (from BG, LV, PL, ES) had based their estimates on the findings of surveys conducted amongst young people and Hungary and Luxembourg based them on the findings of the Eurobarometer survey of 2010 hence, the estimates cannot be said to be proportional to the general population. 91 National stakeholder interviewees from BE, CY, NL and UK highlighted this as an issue. 92 See online national stakeholder survey 93 See, for example, 2012 Guardian MixMag Survey: Over 72% of UK respondents surveyed were working and over 55% had a degree or higher degree 94 These were from Ministries of Health or public health institutes (11 respondents from BG, DK, FR, DE, IE, LV, LU, NL, PL, ES, UK) or from NGOs / not-for-profit associations (11 respondents from CY, CZ, FI, FR, DE, GR, HU, PL,RO, SE) or from universities research institutes etc. (6 respondents from GR, LU, MT, NL, SI). 95 This refers to the estimate of less than 5%. 96 This refers to the estimate of less than 11-20%. Final Report 34

41 Figure 3.5 Estimates of the prevalence of use of NPS in across 19 Member States 97 (n=64) Of the 28 respondents who were able to provide an estimate, eighteen respondents (from BG, CZ, DK, FI, FR, DE, GR, HU, NL, PL, RO, SI, ES, SE) estimated that less than 5% had used NPS of these 2 were from FR, 2 from DE and 3 from NL. 50% estimated that less than 5% had taken legal highs in the past year. Stakeholders in some Member States estimated usage at 21-30% (CY); 11-20% (CZ, MT, PL); and 5-10% (GR, IE, LV, LU, SE). However, these figures should be considered with caution as the criteria on which the estimates differ in the extent to which they are based on research or more ad-hoc considerations and the population being considered (i.e. whether it is the whole population or a sub-population group, such as young people etc.). Table 3.5 National stakeholder estimates of the proportion of the population that have taken legal highs in the last year Prevalence Less than 5% 5-10% 11 20% 21-30% Bulgaria X Cyprus X Czech Republic X X Denmark X Finland X France X Germany X Greece X X 97 BG, CY, CZ, DK, FI, FR, DE, GR, HU, IE, LV, LU, MT, NL, PL, RO, SI, ES, SE Final Report 35

42 Prevalence Less than 5% 5-10% 11 20% 21-30% Hungary X Ireland X Italy Latvia X Luxembourg X Malta X Netherlands X Poland X X Romania X Slovenia X Spain X Sweden X X Some National Surveys have also attempted to calculate overall use of NPS in the general population. In 2010/11 the UK British Crime Survey 98 asked over 27,000 respondents from representatively-sampled households about use of mephedrone in a year-long period 2012/11 (during which the substance was banned) it found that 1.4% of all respondents aged between 16 and 59 had used mephedrone in the last year this was the same level as use of ecstasy. A German study, launched by the Ministry for Health 99, which looked at the prevalence of use of Spice amongst the general adult population (aged 18-64) in comparison with amphetamines, LSD and ecstasy found that prevalence for Spice was much lower at 0.8% lifetime prevalence / 0.4% last year prevalence. In Ireland the National Advisory Committee on Drugs conducted a Drugs Prevalence Survey amongst a sample of year olds in 2010/ The study found that 3.5% of the 7,669 surveyed in Ireland and Northern Ireland had taken NPS within the last year. This included 6.7% of year olds, but only 1.0% of the year olds surveyed. There was no information on lifetime prevalence. Romania reports a significant problem with legal highs : an official population survey found that 1.9% of the population use legal highs and there have been other (unofficial) estimates that half a million of young people having used legal highs See Home Office Statistical Bulletin: Drug Misuse Declared: Findings from the 2010/1British Crime Survey Available at: 99 Werse, B (2009) Spice, Smoke, Sense & Co. Herbal Mixtures Containing Cannabinoids: Use and Motivation for Use against the Backdrop of Changing Laws Federal Ministry of Health - Division 125: Addiction and Drugs, commissioned by Goethe-Universität Frankfurt a.m., FB 04, Centre for Drug Research. Available at: Information provided in the case study interview with a Romanian support organisation. Final Report 36

43 Table 3.6 Overview of prevalence of use in the general population (DE, IE, RO, UK) Member State Population size Age range Substance Type of prevalence Germany NI Spice Lifetime 0.8% Past year 0.4% Ireland ALL Past year 3.5% Romania NI NI ALL Lifetime 1.9% United Kingdom Mephedrone (controlled at time of survey) National studies and GHK Case Studies Prevalence of use amongst young people Lifetime 1.4% Percentage There is strong evidence to support the claim that NPS use is predominant amongst young people. The 2011 Eurobarometer "Youth attitudes on drugs" 102 found that on average 5% of EU citizens aged participating in the survey reported having used new substances at least once in their life, with a peak of 16% in Ireland, and close to 10% in Poland, Latvia and the UK. Similarly, while the figures for last year use of mephedrone in the UK and use of Spice in Germany (see above) were quite low, the proportion of users amongst young people surveyed is much greater. The British Crime Survey 2010/11 found last year mephedrone use amongst year olds was 4.4% (over twice as much as use amongst the general population) 103 and the Irish NACD report found that while 6.7% of year olds had tried NPS, only 1.0% of year olds had done so. The German Study on Spice also concluded that lifetime prevalence decreased notably amongst higher age groups: lifetime usage of Spice amongst the age group is 1.9% and 1.8% amongst the age group as compared with 1.0% amongst the group; 0.3% amongst the year olds and 0.1% amongst those aged In the groups up to age 64 years, 12 month prevalence is 0%. Figure 3.6 Lifetime prevalence of use of Spice, Germany 2 1,8 1,6 1,4 1,2 1 0,8 0,6 0,4 0, yrs yrs yrs yrs yrs yrs % of sample population Source: Werse, B (2009) 102 European Commission, Flash Eurobarometer 330, Youth attitudes on drugs, Home Office Statistical Bulletin (as above). As mentioned, mephedrone was controlled at the time the survey was undertaken. See also: Final Report 37

44 Indeed, amongst young people in some Member States, the use of NPS appears to be growing. A Polish study 104 conducted among 1, year-old students found that while 3.5% of the young people surveyed in 2008 had tried NPS in 2010 this had risen to11.4% of those surveyed. Of the 2010 figure, 7.2% had tried the NPS in the last 12 months (compared to 2.6% of the students surveyed in 2008) and 1.1% in the last 30 days. By contrast, the Spanish State Survey on Drug Use in Secondary Schools (ESTUDES) 105, undertaken in 2010, shows lifetime prevalence for the consumption of NPS amongst 14 to 18 year olds to be only 0.7% - of these 0.6% had consumed the NPS in the last 12 months and 0.5% in the last 30 days. Table 3.7 Overview of prevalence of use in the general population (DE, IE, RO, UK) Member State EU (Eurobarometer) Population size Age range Substance Type of prevalence ALL Lifetime 5% Czech Republic 106 NI ALL Lifetime 4.5% Germany NI Spice Lifetime 1.85% Ireland NI ALL Past year 3.5% Poland ALL Lifetime 11.4% Slovak NI ALL Lifetime 5% Republic 107 Spain NI ALL Lifetime 0.7% United Kingdom Mephedrone (controlled at time of survey) Source: National studies and GHK Case Studies Prevalence of use amongst specific user groups Lifetime 1.4% Percentage Use of legal highs also seems to be linked to use of other substances in some cases. A German study into the use of Spice found that most users were those who were experience cannabis users, and that few adolescents surveyed without previous experience of illicit substances had tried Spice 108. Specific groups such as clubbers may also be more likely to 104 Reviews and Diagnosis 19 Table 121, page 154 See also: and (English versions) 105 Statistics provided by the Spanish respondent to the online national stakeholder survey. For more information on ESTUDES, see: for more information. 106 Czech National Monitoring Centre for Drugs and Drug Addiction (2010) Annual Situation Report. Available at: rug_situation 107 This was reported by a Slovakian respondent to the online national stakeholder survey and figure is said to be based on the findings of the European School Survey on Alcohol and Other Drugs (ESPAD) for Slovak Republic in According to the ESPAD website ( ) the 2011 ESPAD Report will be released May 31, 2012, although questionnaires for 2011 are available now and it is unclear which questions related to NPS. 108 Werse, B (2009) Spice, Smoke, Sense & Co. Herbal Mixtures Containing Cannabinoids: Use and Motivation for Use against the Backdrop of Changing Laws Federal Ministry of Health - Division 125: Addiction and Drugs, commissioned by Goethe-Universität Frankfurt a.m., FB 04, Centre for Drug Research. Summary of results and methodology available from: Final Report 38

45 take legal highs. For example, the MixMag survey carried out in 2010 in the UK found a higher prevalence of use of mephedrone amongst those surveyed (i.e. young people in the clubbing scene) than the prevalence of the general population as presented above. In addition, research into drug use in the nightlife sector was undertaken in 2010 in the Czech Republic finding that lifetime use of mephedrone was at 3.8%, of piperazines at 2.6%, and spice at 3.3% 109. Box 1 provides more information on the profile of NPS users in the EU. Box 2 Profile of NPS users in the EU Young people As described above, young people are one of the largest user groups on NPS. A recent study into use of NPS by young people in Romania 110 found that the NPS users captured in that survey are often socially integrated middle class children and teens who use NPS openly and that there is significant use amongst children aged up to 15 years. However, according to a representative of a support group there, young consumers are more prone to abuse and are more likely to be taken to hospital for reactions to legal highs. Drug addicts Certain synthetic substances', some of which including prescription medicines but also new psychoactive substances, are reported to have replaced heroin amongst drug users in Cyprus, Hungary and Romania 111. Similarly in Hungary it has been reported that heroin users shirted towards use of mephedrone. In Romania s capital, heroin users switched to amphetamine-type new psychoactive substances which are cheaper than heroin and legal. As a result use of injections as a method for intake of NPS increased, as did medical emergencies and undocumented drug-related deaths reported by NGOs. Experienced / experimental drug users In some Member States the main user group are those who are habituated to consuming drugs, but who would not consider themselves addicts per se. These are experimental drugs users who try out new psychoactive substances out of curiosity. This is the case in the Netherlands, where the user group are called "psychonauten" these are often well-educated people (e.g. students) in their mid-twenties, who have an interest in learning more about drugs 112. Novice drug-users NPS are also used by people who would like to try illicit substances, but either do not know any drug dealers or do not want to use something that is illegal. For example, in Romania, in addition to their use by young people, people using synthetic cannabinoids have included those who would like to use cannabis but they do not know any drug dealers and decided to try synthetic cannabinoids (Spice) 113. A recent cohort survey of use of mephedrone amongst night-time economy customers in four town centres in Northern England also suggested that mephedrone (which at the time of the study was already controlled) was added to existing polydrug repertoires, rather than significantly displacing use of established illegal drugs or acting as a gateway for initiation into drug use. 114 dba/drogenundsucht/illegale_drogen/heroin_andere/downloads/kurzbericht_spice_smoke_und_co_engl_ _Drogenbeauftragte.pdf 109 This was reported by the Czech respondent to the online national stakeholder survey. 110 See Botescu, Andrei (2011) Research Report Evaluating new synthetic drug use - risks concerning children and youth in Romania. Funded by IrishAID and UNICEF Romania. 111 See online national stakeholder survey. 112 See Netherlands Case Study 113 See Romanian Case Study 114 See Measham, F., Moore, K., & Østergaard, J. (2011). Mephedrone, Bubble and unidentified white powders: The contested identities of synthetic legal highs. Drugs and Alcohol Today, 11(3), , Final Report 39

46 Specific cultural groups (e.g. electronic music fans, LGBT) Electronic music fans are also amongst those most inclined to use legal highs particularly in the United Kingdom. 115 A clinic set up in the United Kingdom specifically to treat users of legal highs and other recreational drugs (e.g. mephedrone, GBL, crystal meth, cocaine and ketamine) sees two main groups of users as patients: young (late 20s/early 30s) heterosexual people in higher education or full-time employment and homosexual men of the same age range. These groups are characterised by the fact that they use the substances as party drugs or uppers. There is some variation between Member States in the extent to which NPS are used in the EU. In countries such as the Netherlands the use of NPS is negligible, whereas in others (e.g. Poland) some national stakeholders perceive NPS to be a big or even greater a phenomenon as illicit drugs. Reitox National Focal Points (NFPs) were asked to give an evaluation of how the NPS problem compares with that of illicit substances. In most Member States, the NFPs responded that the illicit drug problem remained more serious; however a few (HU, LV, MT, PL, SE) signalled that the NPS problem had reached the same levels or beyond those of the illicit drug problem 116. Table 3.8 Responses to the statement: the NPS problem in my country is relatively small compared to other problems in the field of illicit drugs (n=24) Response Number of respondents Responding countries % Strongly agree 4 FI, DE, NL, PT 17% Agree 10 AT, BG, CR, CY, CZ, DK, GR, IT, NO, RO 42% Neither agree, nor disagree 4 FR, LT, SK, TK 17% Disagree 2 MT, SE 8% Strongly disagree 3 HU, LV, PL 13% No response 1 UK 4% Total % Source: GHK online survey of Reitox National Focal Points and Europol National Units According to the results of the GHK online user survey of users, usage ranged from one-off experimentation (11 users) and those who had used NPS only a few times so far (9 users), through occasional or yearly use (21 respondents) to much more regular use on a monthly, weekly or daily basis. In addition, 10 respondents (18%) were former users i.e. they had used NPS either frequently or as a one-off in the past, but had then stopped usage. 115 See, for example, Wood, Measham and Dargan (2012) Our favourite drug : prevalence of use and preference for mephedrone in the London night-time economy 1 year after control Journal of Substance Use, April 2012; 17(2): This data is provided as an indication only. In order for these statements to provide actual information as to the state of use / harm of NPS in the Member State one would need contextual information on the scale of use of illicit drugs and the harms they cause also to get an accurate picture. Final Report 40

47 Figure 3.7 Frequency of use amongst users of NPS in the EU (n= 128) 117 Source: GHK online survey of users, GHK analysis Of those who used NPS on a monthly basis (22 respondents), 16 gave further specifications with usage varying from one to six times a month. Of those who use NPS weekly (22 respondents), 20 further specified the frequency; this varied from two up to four and five time per week. ; One female Finnish respondent stated that she used to use them five times per week, but as she is trying to 'quit', had reduced her intake to monthly; another Finnish male stated that took them from 4-5 times a week to once a month; and a final Finnish male stated that his usage varied from once every two weeks or so to daily use Demand for new psychoactive substances / motivations for their use There are many reasons why people use new psychoactive substances. The main reason for the demand and use of new psychoactive substances concerns the reported benefits by users (e.g. pleasure, performance enhancement), which links to the reason why people use psychoactive substances in the first place This may include using legal highs to get ahead for example to enhance focus when studying120. One of the main motivations for trying or using NPS amongst users surveyed as part of this assignment was curiosity with over half of the respondents surveyed (31 respondents) citing this as a reason. The joint second and third greatest reasons were to replace illicit drugs or because the legal highs were offered by a friend. The least common reason given by respondent was to fit in to a group. Figure 3.8 provides an overview of reasons for using / trying new psychoactive substances given by users. 117 The majority of respondents were from Poland (38%), Germany (27%), Romania (17%) and Finland (10%). 118 Feedback from expert seminars undertaken as part of this study 119 P. Reuter, Options for Regulating New Psychoactive Drugs: A review of recent experiences and an analytic framework. 120 J. Birdwell, J. Chapman and N. Singleton, Taking drug seriously A Demos and UK Drug Policy Commission report on legal highs, 2011 Final Report 41

48 Figure 3.8 Users reasons for using / trying new psychoactive substances (by proportion of respondent, n=128) Source: GHK online survey of users Availability and legality Availability and legality also seem to be two important drivers, one prevailing over the other depending on the substance, cultural factors and/ or the country. Indeed, if availability seemed to be the main factor for mephedrone use, legality seemed to be the one for synthetic cannabinoids use 121, although this may differ from one country to another and may also depend on the strictness of national illicit drug policies. For example, the use of "Spice" products over cannabis may be interlinked to employment/ other drug testing procedures (e.g. road safety tests) aimed at detecting illicit drug use 122. Another factor may also concern to the availability and quality of 'traditional' illicit substances on the market, which have 'known effects' for many users. Indeed, in Romania, it was suggested that it was due to the limited availability of illicit substances, coupled with an increased demand for such substances, that legal highs became so popular in Romania 123. According to GHK online survey of national stakeholders, new psychoactive substances are considered to be readily or very readily available in most Member States (AT, BG, DE, BE, DK, FR, HU, IE, IT, LV, LU, NL, PL,RO, SK, SI, SE, UK) mainly due to the ease with which they can be accessed through the Internet. In some Member States, national stakeholders had conflicting opinions as to availability 124 ; however, only stakeholders in Greece, France and Netherlands expressed the view that there was hardly any availability of NPS. In other Member States (CY, CZ, EE, FI, GR, LT, MT, ES) there is considered to be more limited availability. Figure 3.9 provides an overview of the responses to the GHK online survey of national stakeholders. The Internet has undoubtedly played a large role in making NPS widely available 125 first by providing a source of information and the tools for publicising new 121 F. Meacham, K. Moore, R. Newcombe, Z. Welch, "Tweaking, bombing, dabbing and stockpiling: the emergence of mephedrone and the perversity of prohibition", in: Drugs and Alcohol Today, Vol. 10:1, p EMCDDA, Understanding the Spice phenomenon, Lisbon, See national stakeholder survey. 124 See Annex 6 for an overview of the number and background of responding stakeholders from each Member State. 125 J. Birdwell, J. Chapman and N. Singleton, (2011) Taking drug seriously A Demos and UK Drug Policy Commission report on legal highs Final Report 42

49 substances on the market, as well as providing a pseudo-legal means of buying psychoactive substances i.e. without having to go through a drug-dealer (for example) and also by facilitating the emergence and growth of new manufacturing and distribution centres many of which are based outside of the EU 126. Figure 3.9 Availability of new psychoactive substances as reported by national stakeholders Source: GHK online survey of National Stakeholders Other drivers of use Individuals responding to the GHK online survey of users, when asked to identify any benefits of legal highs, identified legality (in comparison with controlled substances) as a key advantage (23% or 29 respondents). The next most common benefit identified was the effect given by NPS (17%, 22 respondents), followed by the price (7%). Other benefits identified were the availability of NPS (5%), and their purity (4%), quality or variety (2% each. The largest number of respondents (27%) however stated that there were no benefits. Figure 3.10 illustrates the number of users surveyed (54 in total) that identified each benefit. 126 Ibid (Birdwell and Chapman 2011) Final Report 43

50 Figure 3.10 Perceived main benefits of legal highs Source: GHK online survey of users As regards to demand for NPS, studies suggest that there are also links between the legal status of the substance and the safety perception by the consumer. The assumption is that these substances are "legal and therefore safe" and this can be an additional driver for their use 127. The risks associated with NPS have been generally modest and most importantly, localised, meaning that a) substances on the EWS list have raised limited problems with some notable exceptions; and b) they are generally confined to one Member State at a time (e.g. mephedrone in the UK). There have also been no major catastrophes caused by the use of new psychoactive substances in the form of high number of deaths, serious injuries or infections, serious widespread violence and organised crime 128, at least not to the extent comparable with illicit drugs. In addition, legally obtained substances may often be of better or known quality and therefore safer to use 129. Information gathered for the risk assessment report on Mephedrone showed that in the UK, motivations for using the substance were 'value for money', consistency of product quality, fewer side-effects compared to other stimulants and short duration of effect, making it more 'manageable' Potential adverse health and social harms of some new psychoactive substances As mentioned, to date, the health and social harms of NPS have been comparatively lower than the more traditional psychoactive substances (e.g. alcohol, tobacco and illicit drugs). This may be due to the emergent nature of NPS which has not allowed enough time for experts to gain sufficient knowledge of associated harms, as well as a result of the dynamic nature of the NPS market which makes it difficult to identify consistent patterns of harm. In recent years, several studies have been published that aimed to assess the harm of various 127 ACMD, Consideration of the Novel Psychoactive Substances ( Legal Highs ), See: Caulkins and Coulson (2011) 129 This is based on evidence obtained through expert workshop held as part of the study. 130 EMCDDA, Report on the risk assessment of mephedrone in the framework of the Council Decision on new psychoactive substances, no. 9, Lisbon, 2011, p. 114 Final Report 44

51 psychoactive substances, including both licit and illicit ones 131. As the table shows, various potential harms can be associated to substance use. Table 3.9 Some categories of adverse effects of substance use Category Type Example Physical harm Acute Fatal poisoning, cardiac arrest Chronic Intravenous harm Psychosis, lung diseases Blood borne infections (HIV/ Hep) Dependence Intensity of pleasure High pleasure encouraged repeated use; risk of tolerance Psychological dependence High dependence potential, more difficult to withdraw Social harms Intoxication Accidental damage D. Nutt et al (2007) Other social harms Health care costs Violence Emergencies, illnesses According to the opinion of national stakeholders surveyed for this study, the greatest harms or risks posed by NPS are adverse health effects and behavioural effects (see Figure 3.11). Figure 3.11 Key negative effects / harm of the main legal highs present in the Member State (n=64) GHK online survey of national stakeholders (64 respondents across all 27 Member States) 131 D. Nutt et al (2007) "Development of a rational scale to assess the harm of drugs of potential misuse", in: The Lancet, Vol. 369, n. 9566, p ; J. van Amsterdam et al, (2010) "Ranking the harm of Alcohol, Tobacco and Illicit Drugs for the Individual and the Population", in: European Addiction Research, Vol. 16, n. 4, p ; D. Nutt et al (2010)"Drug harms in the UK: a multicriteria decision analysis", in: The Lancet, Vol. 376, n. 9752, p Final Report 45

52 However, the consequences of use of new psychoactive substances are generally poorly evidenced or documented. For example, some cases of harm to health may have gone undetected by service providers (e.g. healthcare and social services), who have a lack of knowledge of the presence of certain new psychoactive substances 132 and under-reporting may also be an issue. An overview of the EMCDDA s risk assessment reports illustrates the difficulty of assessing the risks associated with new psychoactive substances soon after they appear on the market. In addition, there is a lack of comprehensive and comparable information with regard to historic trends and future projections of use 133, which complicates any assessment of the scale and magnitude of possible harms. The harms to health and society described in this section relate to a limited number of new psychoactive substances, mostly the ones that have gone through risk assessment, and that were therefore considered to represent a possible risk to human health. However, the largest majority of other new psychoactive substances reported through the EWS did not trigger the launch of a joint report by the EMCDDA and Europol, because they were not considered as an EU 'threat' as well as because no explicit reports on related harms were identified as linked to their use. Hence, the effects presented in this section are likely to over-estimate the health and social risks of new psychoactive substances, considering that the substances composing this group are very heterogeneous and their use can cause very different consequences Health harms Physical and psychological harms associated with some new psychoactive substances can take different forms (for more details, see annexes 4 and 6).There are potential risks of acute harm and toxicity linked particularly to certain new psychoactive substances similar to controlled drugs such as cocaine, MDMA and amphetamines, including potential risk of overdose for the most potent amphetamine-like stimulants such as methamphetamine 134. Acute toxicity can result in significant agitation, psychosis, delirium, tachycardia, hypertension, chest pain and seizures 135. In Poland, one of the respondents to the GHK online survey of national stakeholders reported more than 200 poisoning cases related to legal highs in Perceived effects of cathinone stimulants like mephedrone are dose related and include euphoria, increased energy, feelings of empathy, increased libido, sweating, tachycardia, headache, and teeth grinding. For mephedrone, the limited research so far suggests that its patterns of use and potential for misuse are similar to those of cocaine, and that excessive consumption can result in emergency presentations characterised by extreme agitation, chest pain, and sweating 137. Use of mephedrone may also be linked to short-term psychosis 138. Some fatalities have been reported in relation to mephedrone: in the UK, the substance was linked to 42 deaths 139. However, the identification of a substance in a toxicology sample does not necessarily mean that it caused or contributed to death. Fatalities have also been reported in relation to pregabalin (also known as "Lyrica", in FI, SE and UK), to MDPV (in FI 132 In an interview with a UK-based clinician who has recently opened up a clinic specifically for users of club drugs including some legal highs, users seeking medical attention are often put off by the fact that GPs have never heard of the substances and lack understanding. 133 J. Birdwell, J. Chapman and N. Singleton, Taking drug seriously A Demos and UK Drug Policy Commission report on legal highs. 134 ACMD, Consideration of the Novel Psychoactive Substances ( Legal Highs ), Ibidem. 136 National stakeholder online survey. 137 See ACMD report (2010) Consideration of the Cathinones: See information provided by the Club Drug Clinic below. 139 Ibidem. Final Report 46

53 and UK), to para-methoxyamphetamine (PMA) and para-methoxymethylamphetamine (PMMA) (in NL and NO), and desoxypipradrol (2-DPMP) (in UK) 140. Another popular legal high, Spice contains synthetic cannabinoids (the psychoactive components) which may have a greater potential to cause harm than THC in natural cannabis plants. JWH-018, one of the synthetic cannabinoids, may have more psychoactive potential than 'natural' THC in Cannabis, with a risk of severe psychiatric complications in case of accidental overdosing 141. In Germany, the main groups of 'legal highs' identified so far are synthetic cannabinoids and cathinones. According to a national stakeholder: In connection with so-called herbal blends and bath salts, we could cite numerous instances where the use of various "legal highs" was associated with serious health problems requiring hospitalisation and, in some cases, even ICU care. The mostly young users suffered from nausea, circulatory failure and syncopes, as well as psychological problems such as disorientation, confusion, acute psychoses, hallucinations and delusions. In one case, rhabdomyolysis occurred involving the risk of renal failure. In some cases, moreover, use of these substances (primarily cathinones) is known to have led to violent acts and aggressive behaviour. Even isolated fatalities have occurred in Germany (as of 21 December 2011: 2 cases), that are linked to the use of so-called herbal blends. Italy also reports that JWH 018 and the JWH 073 and other cannabinoids identified in 2011 provoked 18 cases of intoxication 142. As Figure 3.12 illustrates, most respondents to the GHK online survey of users providing an assessment of the risks of NPS, identified harm (31% / 39 respondents) as the main risk associated with the consumption of new psychoactive substances. Users listed a number of harms based on their experience or perception these included short-term, low-impact harm such as vomiting, overly-active appetite, dizziness through mild psychosis, paranoia, anxiety, to stomach disease, cardiac arrest, respiratory problems, and death. 143 Twenty per cent of respondents (26 respondents in total) identified the lack of understanding of the effects of NPS as a main risk, and a further 10 respondent (8%) identified either dependence or harm and dependence as the main risks. Other risks identified included the possible lack of purity of NPS. 140 EMCDDA Europol, 2010 Annual Report on the implementation of Council Decision 2005/387/JHA, EMCDDA, Understanding the Spice phenomenon, See online national stakeholder survey. 143 Online user survey; 20 respondents (30%) gave no response to this question. Final Report 47

54 Figure 3.12 Main risks associated with the consumption of NPS according to users (n=128) Source: GHK online survey of users In London (UK) a new Club Drug Clinic 144 has been recently set up at the Chelsea and Westminster Hospital to deal with special cases related to the misuse of recreational drugs including psychoactive substances. It found that in its first year of opening the most common health complaints were those associated with substances which are now controlled in the UK, namely: GBL, mephedrone and ketamine, as well as crystal meth. The clinic reports that, to date, they have seen few problems associated solely with use of new psychoactive substances 145 but it is highly common for patients attending the clinic to use them e.g. cathninones, M-Ket, Ivory Wave, and NRG-3 - alongside illicit substances, such as those listed above 146. According to a national stakeholder, the greatest problem associated with legal highs in Austria was in relation to GBL which caused some near fatal health problems in some users 147. Box 3 Club Drug Clinic The Club Drug Clinic is a drug addiction support service aimed at treating persons suffering from addiction and other psychological or physiological issues resulting from use of drugs typically associated with the clubbing community, such as ecstasy and cocaine, as well as newer psychoactive substances (such as mephedrone and ketamine). According to the Clinic s founder, such drug users are commonly put off using general drug support groups. The Clinic was set up in April 2011 as a two-year pilot though the Clinic s managers are currently searching for new funding to extend this. In addition to treatment, the Clinic provides telephone advice (e.g. to users, parents of users, etc.), training on NPS to institutes (e.g. universities, clubs), and research on new legal highs (publications upcoming). The Clinic currently has around 7 part-time staff which include nurse(s), a psychologist, family therapist and at least one addiction psychiatrist. One of the key features of the Clinic is that it is open access i.e. patients may use it The Clinic reports only two patients who attended the clinic with overuse of Ocean Snow. 146 Perhaps with the exception perhaps of MXE, which is becoming more popular as an alternative to ketamine. The Clinic has seen around 200 patients since its opening in April 2011 (i.e. in the first ten months). 147 No further information provided, see online national stakeholder survey. Final Report 48

55 without referred from a general practitioner or other doctor. The clinic publicises itself mainly through posters in universities and clubs. Except for GBL 148, there is limited information about the potential for dependence among users of new psychoactive substances, but some evidence suggests that amphetamine-like psycho-stimulants are associated with an increased risk of dependence 149. A UK-based online survey 150 on the use of mephedrone reported that among 1,506 respondents who declared that they had taken mephedrone at least once, 14% felt unable to stop taking mephedrone until they had used up all of their supplies;11% reported very strong need for mephedrone after having run out of supply; and 14% described it as very addictive. Only four users (7%) who responded to the GHK online survey of users also identified dependence as a risk 151. The risks of physical and psychological harms might also be higher in case of poly-drug use and joint consumption of alcohol with new psychoactive substances. A recent survey, looking at the number of individuals requiring club medic room assistance while out clubbing, shows that such individuals have problems related to the use of recreational drugs often in combination with alcohol 152. Another health risk of legal highs may be related to the way in which they are consumed. The Romanian limited snapshot study 153 showed that among the group of users of new psychoactive substances participating in the survey, primarily in Bucharest, about one in six (31 respondents) were injecting these substances, which entails the risk of the spread of blood borne infections such as HIV. In addition, the study reports the following serious health problems related to the use of such substances: weight loss, appetite loss, personality disorders, psychotic disorders, prolonged insomnia, cachexia, and death depending on the duration, administration method, and rate of use, as well as the user s lifestyle. At least some of these users already injected heroin, In the GHK online survey of users only 16% (7 out of 45 responding users) perceived the benefits of NPS to outweigh the costs 154. In most cases this was because of a perceived harm of NPS, due to a lack of knowledge about the effects and chemical makeup of the substances. By contrast, another user pointed out that while many NPS have not been tested nor had a long history of user experiences, they were less likely to contain anything like rat poison. This suggests that users have a concern about the content of the substances they consume, but that there is some conflict as to whether illicit or licit substances are more or less likely to cause harm through content. Indeed, lack of knowledge or imprecise knowledge about dosage, content and the associated health risks were perceived to be one of the main risks of consuming NPS (see Figure 3.13). At the same time, the issue of health harms is not necessarily straightforward. An increasing number of reports suggest that when the use of mephedrone was at its peak in the UK, a drop in cocaine overdose deaths had been observed 155. In the Netherlands, over the period of 2007 and 2008, an increase of the use of mcpp and BZP had been observed as cutting agent in ecstasy tablets, possibly due to a shortage of MDMA precursors on the market. In comparison, mcpp and BZP may produce a smaller risk of adverse effects in case of overdose of ecstasy. In short, some new psychoactive substances may replace or reduce the use of other, more harmful substances, which could be considered as an unexpected health benefit. 148 See: Addiction (online version): ACMD, Consideration of the Novel Psychoactive Substances ( Legal Highs ), R.L. Carhart-Harris, L.A. King, D.J. Nutt, "A Web-based Survey on Mephedrone", in: Drug and Alcohol Dependence, Online user survey; 20 respondents (30%) gave no response to this question. 152 D.M. Wood, M. Nicolauo, P.I. Dargan, "Epidemiology of recreational drug toxicity in a nightclub environment", in: Substance Use and Misuse, vol. 44, n. 11, p A. Botescu, Evaluating new synthetic drugs' use risks concerning children and youth in Romania, Data based on 51 respondents to the survey at the time of writing. Since then more users have responded. 155 This is based on evidence obtained through expert workshop held as part of the study. Final Report 49

56 Social harms Social risks related to new psychoactive substances generally include inter alia the impact of the use of a substance on individual users, their family, personal relationships, career and education in society, as well as impacts on the wider community and crime. In addition, long-term social risks may include social exclusion and moral values decay. 156 According to the Club Drug Clinic, social harms may include disruption of the social network - i.e. users may switch their friendship group to an exclusively using friendship group; (relatedly) personality changes, which may lead to changes to relationships; and loss of days at work / university. For example, the clinic reports that patients often come to the clinic when they have reached a stage when their work is at threat. The use of new psychoactive substances may have secondary impacts on society, even though so far very little evidence exists to substantiate any negative social impacts. The overall use of new psychoactive substances may also result in higher consumption of illicit drugs and alcohol 157. Moreover, due to the unknown contents of some products sold as new psychoactive substances (e.g. mephedrone and PMMA) 158, involuntary use of controlled substances may occur. Anecdotal and media reports suggest that use of some new psychoactive substances may lead to violent behaviour and crime. The risk assessment of mephedrone reported a geographically restricted increase in crime amongst intravenous users, including burglary, theft and weapons related crime. This was likely to be linked to a rise in the price of the products following an import ban. There are also reports from Ireland of an increase in teen-related violence and muggings following the use of "head-shop drugs", including mephedrone. At the same time, the report clearly affirms that there is no evidence of an increase in the levels of acquisitive crime resulting from mephedrone use 159. In general, systemic violence and involvement of crime groups may increase when substances often the ones for which there is an ongoing demand in the market are made subject to control measure. A survey among traders of a popular UK dance and clubbing magazine 160 showed that prior to the ban of mephedrone, users would obtain the substance from friends (38%), the Internet (33%), dealers (24%) and head shops (5%). After the ban, they would still obtain the substance from friends, but the purchase over the Internet and head shops had dropped dramatically (together 1%), while the sale via dealers had more than doubled (58%). However, by contrast, legal highs have been shown to be associated with use amongst more affluent, socially well-established and well-educated people 161 who, because they work and have a steady income, are less likely to resort to crime to pay for their substance consumption. 3.4 Problems related to the differences in national approaches to new psychoactive substances Common to all Member States that have recently taken steps to control new psychoactive substances is the importance they have given to implement mechanisms that could more effectively address the rapid increase of new psychoactive substances in the market and respond to the ease at which these new substances emerge in the market 156 A. Botescu, Evaluating new synthetic drugs' use risks concerning children and youth in Romania, EMCDDA Europol, Joint Report on a new psychoactive substance: 4-methylmethcathinone (mephedrone), S. D. Brandt, H. R. Sumnall, F. Measham, J. Cole, "Second Generation Mephedrone: The confusing case of NRG-1", in: BMJ, 2010;341:c EMCDDA Europol, Joint Report on a new psychoactive substance: 4-methylmethcathinone (mephedrone), MixMag Magazine, March See interview with Club Drug Clinic (UK); Botescu (2011) (RO). Final Report 50

57 Just over a third of EU Member States (AT, BG, CY, FI, HU, IE, LT, LU, PL, RO, SE and the UK) have modified their national legislative framework as a response to the emergence of new psychoactive substances since In addition, a new legislation to control NPS is expected to come into force in Denmark in July This may be explained by the fact that not every EU Member State is affected in the same way and with the same intensity by the phenomenon of new psychoactive substances or that the existing legislative measures in other Member States have been appropriate to deal with the phenomenon thus far. Regardless, as set out above, it is clear that market for new psychoactive substances has been rapidly evolving, and joint approaches in the internal market would have clear benefits in providing legal certainly in the EU. Member States' laws and practices to address new psychoactive substances diverge widely. They apply different types of legislation, and have their own identification, risk assessment and control procedures in place, which vary in terms of level of scrutiny, duration, stakeholders involved and outcomes of the process. As a consequence, Member States often introduce their own national control measures with regard to new psychoactive substances, and do so even before the EU has completed its risk assessment process. Such measures are notified to the Commission under Directive 98/34/EC, which sets out a procedure for the provision of information in the field of technical standards and regulations. These differences in national legislation and practical approach can create a risk of distortion of the normal conditions of the activities within the Internal Market, with possible undesirable or unintended consequences for neighbouring countries. This is well illustrated by the apparent consequence of the Polish decision to close around 1,200 smart shops on its territory in December 2010, with a Polish company opening more than 30 smart shops, specifically in the bordering regions such as in the Czech Republic that had not seen such shops in the country before. There is also evidence to suggest that once a substance is controlled in a Member State its legal import becomes prohibited and consequently the importation of that substance might be directed to a Member State where it is legal 162. This distortion may lead to undesirable consequences. At the same time, there are legitimate concerns about some new psychoactive substances, which may pose a threat to public health and on which responsible authorities must act National legislation applicable to new psychoactive substances Frameworks used for regulating new psychoactive substances Four main frameworks are used by Member States to regulate the use and availability of substances that may be consumed by humans, which in the ascending order or strictness include 163 : Foodstuffs legislation; Regulations relating to specific commodities, such as tobacco and alcohol, but also substances with other uses, such as solvents; Medicines regulations; and The regulation of illicit substances covered by international conventions and related national and domestic legislation. New psychoactive substances are primarily controlled under drug control and medicines legislation in the Member States 164. Medicines legislation is primarily used to supplement the illicit drugs legislation, as most of new psychoactive substances are not controlled under 162 The legitimate distributors of new psychoactive substance do not intend to break the law by importing substances which are forbidden and for which sanctions apply. 163 Reuter, P (2011) Options for regulating new psychoactive drugs: a review of recent experiences Medicines legislation, which is used by some Member States to limit the manufacture and marketing of new psychoactive substances while not criminalising possession for personal use and is used in at least the following Member States: BE, BG, CZ, LU, FI, UK, FR, SK, LU, NL, SI, SE. The use of medicines legislation does not imply that the new psychoactive substances in concern would be medicinal products but rather that medicines legislation allows for fast control of such substances in the market. Final Report 51

58 former as it is time consuming to list them in schedules. Listing under the medicines legislation allows exerting some control over these substances, with the sanctions for users and those possessing for personal use being less severe than those envisaged under drugs legislation. Member States also use other legislation to regulate and control the market for new psychoactive substances, such as: consumer protection (LU, SI, SK, UK, RO, BE, FR, IT), product safety (LU, SK, UK, BE, RO), food safety (BE, NL, PL, UK) and dangerous chemicals (LT, RO, SE, UK). For instance, measures on the sale of new psychoactive substances based on consumer protection regulation have been implemented in Italy and in the United Kingdom, where "Spice" and mephedrone were confiscated from suppliers on the basis of inappropriate labelling. At least two Member States (PL and RO) require economic operators to obtain a market authorisation from consumer protection authorities before commercialising a new psychoactive substance. However, these measures are somewhat ambiguous as substances that have psychoactive effect (similar to illicit substances) are in practice not allowed which means that in practice authorisation is never obtained. More recently, other legislative measures have been undertaken in some Member States to deal with the variety and increasing number of new psychoactive substances identified in the market. For example: The UK has implemented importation bans for certain, internationally traded substances. Recently, an emergency measure has been adopted, allowing for a temporary ban of a new psychoactive substance that gives a cause for concern. Luxembourg allows the banning of products where there is reason to suspect they would harm public health The law in Sweden allows for destruction of substances whereby authorities have the right to seize and destroy substances that are considered dangerous to health. The law aims to prevent the spread of hazardous substances that are classified as narcotic or dangerous to health 165 In accordance with Directive 98/34/EC laying down a procedure for the provision of information in the field of technical standards and regulations 166, Member States have to report to the Commission any new or amended technical regulations 167 that may impede the internal market for goods. When Member States seek to limit the marketing or use of a chemical substance on grounds of public health, or the protection of consumers or the environment, they "shall also communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate". Member States "shall postpone the adoption of a draft technical regulation for three months from the date of receipt by the Commission" unless they are obliged to introduced it immediately "for urgent reasons, occasioned by serious and unforeseeable circumstances relating to the protection of public health or safety, (.) also for public policy, notably the protection of minors". Few Member States have notified control measures related to new psychoactive substances to the Commission since 2005, although there has been a rapid increase since The countries notifying measures reflect in part those most affected, although some Member States, including the UK, do not notify. Member States increasingly request the application of 165 The investigation and decision of destroying the substances is mainly dealt within the Administrative Procedure Act rather than under a illicit drugs legislation OJ L 204, , p Art. 1(9): "Technical specifications and other requirements, including the relevant administrative provisions, the observance of which is compulsory, de jure or de facto, in the case of marketing or use in a Member State or a major part thereof, as well as laws, regulations or administrative provisions of Member States, except those provided for in Article 10, prohibiting the manufacture, importation, marketing or use of a product". 168 Most notifications received by the Commission concern amendments of national drug control legislation. From 2005 to 2010, the Commission received 33 notifications, from Sweden (16), Ireland (5), Austria (2), Germany (2) Poland (2), Romania (2), Finland, Hungary, Latvia and the Czech Republic (all 1). The number of notifications increased since 2009: 2005 (2), 2006 (1), 2007 (5), 2008 (2), 2009 (9), 2010 (14). Final Report 52

59 the urgency procedure for reasons of protection of public health, even though the evidence justifying the urgency requests is sometimes not fully documented, or concerns wide ranging legislation covering a variety of individual substances. The most recent development is that some of the notifying Member States present major overhauls of their legislation in this area (e.g. IE, RO and AT) Approaches for controlling new psychoactive substances Most Member States follow an individual approach for controlling new psychoactive substances, meaning that when a substance is to be brought under control, it is added to a scheduled list of controlled drugs and sanction is only applied if the seized substance is chemically identical to any of the listed. As a result of the market dynamics of NPS, this approach has been considered ineffective by some Member States. The listing of individual substances in Decrees is not only time consuming but it also does not prevent any new substances with only slight modifications to chemical structure of the controlled ones to appear quickly on the market, which is set out in section 3.5 below, is a highly common phenomenon. In response to this, just under a third of Member States have adopted generic or analogue approaches to more effectively control NPS. In addition, at least two Member States (FI and DE) are considering whether a generic approach might be possible to implement in these countries. A generic approach is employed in Cyprus, the Czech Republic, Ireland, Lithuania and the United Kingdom and exists alongside the individual approach in Hungary. It will also soon be introduced in Denmark and is being trialled for cathinones in France. The 'generic approach' allows groups of substances to be controlled together. The group is usually defined either by reference to the way that the group of substances are structurally derived i.e. a compound derived by replacement or substitution of specific elements within it; or by illustrating modifications to a parent molecule. 169 An advantage of this system is that it reduces the number of products similar in activity/harm to controlled substances that can be put on the market. In Cyprus, while the generic approach was only recently introduced, it is aimed at increasing the speed with which substances can be controlled. The analogue approach allows Member States to ban all substances which have similar properties and could be classified as one group e.g. cathinones. This system is used in Luxembourg and will soon enter into force also in Austria. An individual approach is supplemented by an analogue system in Bulgaria and Italy. An analogue system controls substances that are related in terms of their pharmacological activity e.g. effect on the nervous system / brain 170. An advantage of this system is that it reduces even further the number of products similar in effect to controlled substances that can be placed on the market. However, an important disadvantage of the approach is that, while it may be possible to prove that the chemical structures of two substances are similar, it takes longer (i.e. more testing) to demonstrate that the substance can have similar effects as the controlled substance. An increasing number of Member States consider the benefits of generic or analogue approaches because they allow for simultaneous control of chemically related substances. However, the legal uncertainty surrounding the control of this type (the exact substance is not listed in the legislation and users hence may not know that they are taking something which is potentially illegal) makes it difficult to implement such approaches in all Member States 171. In addition, especially judicial decisions on substances under the analogue 169 See EMCDDA report on legal responses to new psychoactive substances in Europe (2009): See: The stakeholder consultations indicated that in Member States where such approaches were not adopted, there was recognition of the future need for them to also consider such approaches because the current system could not effectively control the possibility for multiple closely related NPS appearing on the market, as exemplified by the emergence of synthetic cannabinoids, for example. Final Report 53

60 approach can be challenged rather easily, given the technical difficulties to in proving that a substance has a similar effect. Table 3.10 provides a summary of the approaches used for regulating new psychoactive substances in each Member State. Table 3.10 Member State legal approaches to new psychoactive substances172 Member State Type of legislation Individual Analogue Austria X * Generic Further Comments On 29 th December 2011, Austria adopted legislation to introduce an analogue approach. The146th Federal Law on protection from health hazards associated with new psychoactive substances (New-Psychoactive Substances Act, NPSG) will soon enter into force Belgium X Bulgaria X X Cyprus X The individual listing system is supplemented with the analogue system: "analogue" is defined in the Narcotic Substances and Precursors Control Act as any substance which is not listed in the Schedules of narcotic substances but which has a chemical structure matching that of a narcotic substance and causing similar effect on the human organism. Analogues are subject to the same measures and control as narcotic substances. The Generic approach was introduced through amendments to law L. 29/77 in June Czech Republic X Denmark X * A bill aimed at introducing the generic system as a supplement to the individual system was presented to Parliament and will likely enter into force on 1 st July Estonia X Finland X (*) France X * Germany X (*) Finland is expecting to explore in the future the possibility for introducing a generic approach France is currently trialling the generic approach for substituted cathinones. Germany is current considering to implement a generic approach in the future Greece X Hungary X X From 1 st March 2012 new psychoactive substances will be controlled through individual listing as well as a generic system. Ireland X 172 Key to table: X denotes that the approach is currently implemented in the Member State, whereas * denotes that the approach is currently being considered to be implemented in the Member State. (*) Denotes that the member State is expecting to consider in this approach in the future. Final Report 54

61 Member State Type of legislation Individual Analogue Italy X X Generic Further Comments Italian legislation is based on a chemical definition of a substance, and it is also possible to classify different groups or types of drugs. Latvia X Lithuania X X Generic approach introduced through amendment to the Law on Control of Narcotic and Psychotropic Substances (26 October 2010) Luxembourg X Malta Netherlands X X Poland X (*) Portugal Romania X (*) Slovakia Slovenia Spain Sweden X X X X United Kingdom X This is a new approach historically NPS were controlled through an individual approach. Source: Stakeholder consultations as part of GHK study and Legal responses to New Psychoactive substances in Europe (2009) Different systems for the assessment of the risks posed by the substances Risk assessments play an important role in the decisions to control new psychoactive substances in the EU. Member States have different approaches and systems in place for the assessment of risks relating to new psychoactive substances. While some Member States have a national risk assessment mechanism, others are more dependent on the risk assessments undertaken at EU level. The authorities and expertise involved in the risk assessments of new psychoactive substances also vary across Member States. For example, six Member States (CZ, DK, EE, FR, IE, PL) do or may provide for the possibility of consultations with independent scientists, while in three countries (AT, NL, UK) risk assessments are performed by scientifically independent bodies. In other Member States, risk assessments are organised by a group of experts hailing from a competent ministries or a related State or Governmental Agencies 173. In Member States which systematically undertake risk assessments for substances causing concern, the structure and focus of these assessments show some similarities. For example, in the Netherlands the risk assessment is carried out by the Coordination Centre for the Assessment and Monitoring of New Drugs and consists of a literature review and 173 Faruk Asicioglu New psychoactive substances: The legal procedure used in European Union Countries and Turkey, Bulletin of Clinical Psychopharmacology, Vol: 20, N.: 4, Final Report 55

62 consultation of an expert network to get an overview of the molecular structure and toxicity of the substance as well as the level of harm expected. The procedure is similar in Finland where the Medicines Agency coordinates and compiles the risk assessment report, gathering information from all relevant agencies, including the police, customs, the Finnish Health Institute, and toxicity knowledge centre. The risk assessment also compares the expected risks and harms to already illicit substances, although no specific harm index exists for this purpose. Five Member States do not perform risk assessments at national level and rely on the system set up by the Council Decision, while twelve Member States provide for such assessment on an ad-hoc basis or as part of general administrative procedure. Seven Member States have some type of risk assessment directly referred to the national drug law or its equivalent 174. Overall, most Member States make a difference between normal and urgency or fast track procedures, the conditions for which are usually integrated in the requirements set for carrying out risk assessments and for adopting legal decisions on a specific substance. In many Member States, the results of the risk assessment (i.e. presenting the level of potential harm detected) will influence the type of legal procedure chosen, as well as its speed. For example, in Member States such Germany, Luxembourg, Slovakia and Sweden, the level of risk established by the assessment will determine whether the standard or the emergency/rapid procedure is more appropriate for dealing with the substance. Moreover, in France, Austria and Norway, cases of urgency will lead to a shortened duration of the risk assessment procedure itself, whereas in the Netherlands the results of the risk assessment affect the speed of the legislative procedure, whilst the speed of the risk assessment itself will also depend on the perceived level of harm 175. Table 3.11 below illustrates the different types of risk assessments used by the Member States. Table 3.11 Types of risk assessments in the EU Reliance on EU RA Use on ad-hoc basis RA as part of general administrative practice with varying degrees of formalism National RA in the main drug law Belgium Czech Republic Latvia Denmark Greece Ireland Lithuania Germany Spain Cyprus Austria Estonia Hungary Luxembourg Romania France Portugal Poland Slovakia Netherlands Slovenia Sweden UK Croatia Finland In addition, Member States have adopted a variety of risk monitoring and risk assessment measures 176. Common to all Member States is that they have a system in place for early warning / notification of new psychoactive substances, but apart from that, measures vary 174 Please note that information was available for 24 of the 27 Member States. Bulgaria, Italy and Malta have not been included. Source: Hughes, B and Blidaru, T (2009) Legal responses to New Psychoactive substances in Europe : Hughes, B and Blidaru, T (2009) Legal responses to New Psychoactive substances in Europe Stakeholders consulted in each Member State sometimes reported different risk monitoring and assessment measures undertaken in their respective Member State. This may partly be due to the fact that some of these measures are deployed in a more informal manner and not always undertaken as part of the official national procedures. Final Report 56

63 considerably. Whereas only few Member States undertake proactive monitoring to detect new psychoactive substances in the market, many Member States undertake research on the chemical structure and toxicology of the substances notified to EWS. Some Member States also undertake research regarding the health and social effects of notified new psychoactive substances as well as investigate the level of involvement of organised crime. Table 3.12 below illustrates the variety of possible approaches undertaken by the Member States, highlighting the differences between the Member States. Final Report 57

64 Table 3.12 Overview of possible risk monitoring and assessment measures undertaken by the Member States177 MS Proactive monitoring to detect new substances on the market Early warning/ notification of a new substance Fast-track procedures to restrict availability and trade Research following early warning/ notification on chemical structure and toxicology Research following early warning/ notification on prevalence of use Research following early warning/ notification on effects on health and social effects Research on the involvement of criminal groups Production of a risk assessment report Advice by/ consultation with expert / scientific committees Consultation with wider stakeholder groups Austria (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) Belgium x (x) x Bulgaria x x (x) x x x Cyprus x x x Czech Republic x x x x x x x x x x Denmark x x Estonia x x x x 177 Key to the table: (-) denotes no response; (x) denotes that not all respondents from the same Member State agreed with this measure being adopted in the country; x denotes that all respondents from the same Member State agreed. However, in many cases this is because one person responded to the question. The persons responding to these questions were one of three types of stakeholders: (i) Ministry of health/national health agency or institute; (ii) Ministry of Interior/Home Affairs; (iii) law enforcement agency. Final Report 58

65 MS Proactive monitoring to detect new substances on the market Early warning/ notification of a new substance Fast-track procedures to restrict availability and trade Research following early warning/ notification on chemical structure and toxicology Research following early warning/ notification on prevalence of use Research following early warning/ notification on effects on health and social effects Research on the involvement of criminal groups Production of a risk assessment report Advice by/ consultation with expert / scientific committees Consultation with wider stakeholder groups Finland x (x) x (x) x x x (x) France x x x x x x (x) (x) (x) Germany x x x x Greece x Hungary (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) Ireland x x x x Italy x (x) (x) (x) (x) Latvia (x) x x (x) (x) (x) (x) (x) x (x) Lithuania x x Luxembourg x Malta (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) Final Report 59

66 MS Proactive monitoring to detect new substances on the market Early warning/ notification of a new substance Fast-track procedures to restrict availability and trade Research following early warning/ notification on chemical structure and toxicology Research following early warning/ notification on prevalence of use Research following early warning/ notification on effects on health and social effects Research on the involvement of criminal groups Production of a risk assessment report Advice by/ consultation with expert / scientific committees Consultation with wider stakeholder groups Netherlands (x) x (x) (x) (x) (x) Poland x x x x Portugal (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) Romania (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) Slovakia x Slovenia x (x) (x) (x) (x) (x) Spain x x x x Sweden x x x x x UK (x) x x x (x) x x x x x Source: GHK online survey of national stakeholders Final Report 60

67 3.4.3 Management and control measures The mechanisms and procedures used for managing and controlling new psychoactive substances vary between the Member States, although most Member States use a combination of different means, ranging from criminal legislation to legislation allowing for a more rapid control of the potential harms caused by new psychoactive substances. Table 3.13 presents an overview of the responses of the National Focal Points regarding the means through which new psychoactive substances are controlled in their respective Member State. According to this information, some Member States have a legislation specific to controlling new psychoactive substances, whereas other Member States do not and they control such substances under other types of legislation, such as medicines and food legislation. This was also referred to in section Regardless of whether specific legislation is in place, other types of legislation are used on regular basis because of the rapidly evolving situation of new psychoactive substances emerging in the market. For example, although Finland introduced a legislative instrument specific to new psychoactive substances in 2011, they still find it necessary to use the medicines legislation in parallel to this because the volume of new psychoactive substances. Irrespective of which legislation is used to control new psychoactive substances, some respondents noted problems relating to controlling these substances, which primarily related to the dynamics of the market and the fact that legislation was perceived to be running behind these rapid developments. Table 3.13 Legislation used to control new psychoactive substances in the respondent s country 178 Specific legislation is in place of controlling NPS Other legislation (e.g. medicines or food) is used on regular basis for controlling NPS There are problems related to controlling NPS with legislation Strongly Disagree or disagree CZ, IT, BG, FR, DE, GR, HU, LV, NL, PT CZ, DK, HU, LT, BG, FR, GR, IT, LV, MT, PT, SK, SE CZ, HU, LV, FR, DE, NO, PL, PT, RO, SK, SE Neither agree nor disagree AT, BG, CY, IT, NL Strongly agree or agree AT, CY, DK, MT, PL, RO, SK, FI, LT, SE AT, CY, DE, NL, NO, PL, RO, FI DK, FI, GR, MT, LT Source: GHK online survey of NFPs Member States also have different approaches with respect to the types of restriction and prohibition measures that can be taken to control new psychoactive substances. All Member States have the option to introduce a permanent control measure making import, production/distribution and sale a criminal offence. In addition to this, some Member States use other market restriction measures such as permanent restriction prohibiting import and/or the production, distribution and sale of new psychoactive substances (e.g. UK, DK, IE, LU, NL, PL, SK, IT, DE, FR, CZ, BG). Some member States, notably the UK, also have the option for a temporary measure 179 to collect further information and undertake additional research before deciding on a permanent control measure. Many Member States also have the options for permanent control making possession a criminal offence (e.g. BE, BG, DK, FI, FR, DE, GR, IT, LI, LU, MT, NL, RO, SK). This normally applies to those new psychoactive substances that have been placed under drug control legislation. Very few National Focal Points provided a response to the question. 179 In the UK these are known as Temporary Class Orders which allow a group of substances to be banned for twelve months before the final decision will be undertaken following risk assessment. During this period possession of the substance will be legal but production, import/ export, distribution and sale is an offence equivalent to Class B drugs. One-year temporary controls already exist in Germany and the Netherlands, but in these member States they can also apply to personal possession. Final Report 61

68 Country Member States appear to have mechanisms requiring the proper labelling of products, placing conditions on marketing and sale of new psychoactive substances or imposing threshold on active components 180. The control of new psychoactive substances is enforced through sanctions, which have consequences to consumers and operators when breaking the law. Common to all Member States is that criminal sanctions are applied on import, production, distribution and sale of new psychoactive substances, particularly for those that are controlled under the illicit drugs legislation. Control through means of other legislation may not lead to criminal sanctions and this is dependent on the specific law of the Member State. Some Member States also apply administrative sanctions on import, production, distribution and sale (e.g. AT, CZ, FI, IT, NL, PL, UK), whereas hardly any Member State applies administrative sanctions on possession, which is largely criminalised 181. This however would primarily in practice apply to those new psychoactive substances controlled under the illicit drugs legislation. Although the difference in types of sanctions is not a problem per se, the fact that there is variation between control measures on substances that occur in many Member States, there is an increased risk that consumers and operators unknowingly break the law, with more or less severe consequences. In addition, the type of legal decision bringing a new psychoactive substance under control and the duration of the procedure also diverge between the Member States. As the standard procedures followed in the Member States can take many months, some Member States have adopted methods to accelerate the standard procedures, notably through rapid procedures (LU, PL, SK, SE) and temporary emergency procedures (DE and NL). The table below provides an overview of the systems in place in 22 Member States for which information was available. Table 3.14 Summary of estimated duration of legal procedures, and the legal text produced Duration of procedure for bringing new substance under control Legal text produced AT 6 months (due to limit quantities requirement) Regulation of the Minister of Health BE About 1 year (standard procedure) Royal Decree (for controlling new substances) CY 6-12 months Order of the Council of Ministers CZ Usually about 1 year Law of Parliament DK DE 2-3 days following recommendation of the National Board of Health Standard listing: minimum 2 months (excluding preparations) Emergency listing: 1 week (excluding preparations) Regulation of the Ministry of Health and Prevention Standard procedure: Governmental Regulation Emergency procedure: Regulation of the Federal Ministry of Health EE Roughly 1 month Regulation of the Minister of Social Affairs 180 It is unclear which Member States have adopted such measures in practice, but it seems that Italy, Bulgaria, Romania, Czech Republic, Netherlands and Poland could take them in theory. Requirement for proper labelling (in BG, CZ, RO); Placing conditions for marketing and sale (BG, IT, NL, PL, RO); Putting thresholds on active components (BG, IT, FR). 181 Criminal sanctions on possession are applicable in at least the following Member States: BE, BG, CZ, DK, FI, FR, DE, GR, IE, LT, LI, MT, RO, SE and UK. Administrative sanctions on possession are applicable in CZ, FI, LV and SI. Final Report 62

69 Country Duration of procedure for bringing new substance under control Legal text produced EL ES 1-2 months (following notification from the National Focal Point) About 5-15 days for the Order s coming into force Joint Ministerial Order of the Ministries of Health and Justice Order of the Ministry of Health and Consumer Affairs FR Minimum 3 months Decree of the Minister of Health IE Generic system: immediate / implicit control Governmental Declaration Order Standard individual listing: about 1.5 months LT National decision: 1-8 months Decree or Order of the Ministry of Health If UN/EU decision: 1-2 months LU Standard procedure: not used in practice Grand-Ducal Decree Rapid procedure: 1-2 months LV [Neither the analogue system nor the individual listing system s standard procedure have yet been used in practice] Law amending the Procedures for the Coming into force and Application of the Criminal Law of Oct 2002 NL Standard procedure: 3-6 months Standard procedure: Order in Council Emergency procedure: 1 week (valid for 1 year) Emergency procedure: Ministerial Regulation PL Standard procedure: Minimum 9 months Parliamentary Law (amending the Act of on counteracting drug addiction) Rapid procedure: about 6 months PT Minimum duration of procedure: 1-12 months Parliamentary Law (amending the Decree- Law 15/93) RO Approximately 4 months Governmental Emergency Ordinance SE Standard procedure: 5-6 months Governmental amendment to the Ordinance on the Control of Narcotic Drugs or Rapid procedure or international decision: immediate application Governmental amendment to the Ordinance on the Prohibition of Certain Goods Dangerous to Health SI Approximately 2 months (Governmental) Decree on completion of the Decree on the Classification of Illicit Drugs SK Standard procedure: at least 3 months Parliamentary Law Rapid procedure: about 1 month UK Generic system: immediate/ implicit control Order in Council made by Her Majesty Standard individual listing: 2-3 months after Final Report 63

70 Country Duration of procedure for bringing new substance under control opinion from the Advisory Council on the Misuse of Drugs Legal text produced Source: EMCDDA, Legal responses to new psychoactive substances, 2009 In addition, the substances covered by control measures in the Member States differ. This is mainly due to the fact that substances may have emerged (and pose risks) in some Member States, while they have not appeared at all in other Member States. However, problems may occur when a Member State decides to introduce control measures on a substance which raises concerns in more than one country, without coordination with other Member States. This may lead onto an internal market distortion, with the import of the substance being diverted towards countries which have no restrictions (yet) in place or with users seeking to obtain the substance from other countries. Most new psychoactive substances are not internationally controlled and BZP and Mephedrone are the only new psychoactive substances that are under EU-wide control as a result of the Council Decision. Other new psychoactive substances are controlled in some Member States such as in the case of synthetic cannabinoids (notably "Spice" and "Spice"- like products), mcpp and MDVP. Moreover, some Member States have recently added many new psychoactive substances to their control schedules, as a response to the large number of these substances appearing on their markets. For example, Bulgaria has added 45 new psychoactive substances to Schedule I of the Law on Drugs and Precursors Control, which includes the listing of synthetic cathinones, and synthetic cannabinoids, as well as new cocaine and amphetamine-like synthetic derivatives. Czech Republic has added 33 new psychoactive substances to its prohibited drug schedules, whereas Latvia added 27 to its schedules between 2009 and 2011 and Romania added 44 new psychoactive substances 182. Finally, GHB has been under international control since 2001 but in order to evade the control of GHB, traffickers turned to GBL which is rapidly converted to GHB when ingested. GBL is legally used and traded in large quantities for synthesis of plastics and industrial solvents and has been in the EU voluntary monitoring list of non-scheduled drug precursors. The European chemical industry has engaged in voluntary monitoring and notification of suspicious transactions concerning all drug precursors on the voluntary monitoring list. Furthermore, some countries (IT, LV, AT, SE, UK, NO) have decided to control GBL under their national drug legislation by making its supply to the general public or possession of the substance for personal use a criminal offence. However, GBL as a new psychoactive substance poses some specific problems, as it is widely used the chemical industry. The majority of new psychoactive substances are produced for their psychoactive effect and not used in mainstream industry as such 183, although their precursors might Problems linked to the Council Decision and related drivers The Council Decision establishes a mechanism for a rapid exchange of information on NPS, for assessing the risks associated with these substances and, if deemed necessary, to submit these to control measures and criminal penalties. Its main objectives are: To ensure rapid common action by the Member States to prevent and combat the possible dangers of NPS. 182 This information is based on responses from Member State authorities to the national stakeholder survey. 183 In addition to GBL, desoxy-d2pm is one such substance. It has been reported to EMCDDA by several Member States and is currently subject to an import ban in the UK. The substance has been used as a chiral agent in NMR analysis. No other such substances have been identified as part of the study. The experts consulted as part of the study have been generally of the view that among new psychoactive substances there would not be substances used directly by the industry. 184 It has not been possible to undertake extensive research on the number of precursors affected. Final Report 64

71 To prevent potential problems with regard to judicial cooperation if an offence which is punishable in one Member State is not punishable in another. Drug precursors, substances that are used in the manufacturing of medicinal products, and those already assessed in the UN system are excluded from its scope. The Council Directive does not replace Member State legislation on NPS. There are six broad steps in the procedure established by the Council Decision for reporting, analysis of risks and the eventual submission of new psychoactive substances to control measures, as set out below: 1) A Member States provide information on a new substance on its market Europol National Units (ENUs) and Reitox National Focal Points (NFPs) in each of the Member States notify Europol/EMCDDA of any new psychoactive substances. Information on the on the manufacture, traffic and use of the drug is then entered into the Early Warning System (EWS) database. The information is also shared with the European Commission and the European Medicines Agency (EMA). New operating guidelines for the Early Warning System were introduced in Information sources used for the EWS include health records from national healthcare system, information from law enforcement agencies especially drug units), national pharmacovigilance systems, academic research and media sources. They then collect this information and report any NPS identified to the EWS via standardised reporting forms. The standardised forms include information such as weight and quantity of any seizures of the substance, biological samples (e.g. body fluids) taken from a user; samples of the substance itself; information on any other substances present in the sample; physical description (form (e.g. tablet, liquid) and colour); circumstances of seizure (production, trafficking, distribution, use, and whether these were small or large scale, and whether organised crime was involved or not); price (where relevant); patterns of use and other possible uses; effects (both those objectively observed and those described by the user); context of use (user group, setting, availability); and any indications of possible risks / harm to individual s health, public health or society at large. This information is re-circulated back to other Member States, and is recorded in the European Database on New drugs (EDND). It also informs Joint Reports and Risk Assessments where necessary. In addition to serving for the purpose of the Council Decision, the information provided to the EWS is put to several uses. First, all reported substances are added to the European Database on drug Dependence (EDND) to which selected members of the EWS network have access. The substances are also listed in the EMCDDA-Europol Annual reports on the functioning of Council Decision 2005/387/JHA, and may be mentioned in the EMCDDA s annual report on the state of drug problems throughout Europe. Reitox also produce biannual progress reports and annual final reports which provide information on the drugs reported to the EWS. In addition, the EMCDDA produces annual thematic papers on particular categories or families of psychoactive drugs, or particular trends in their emergence ) If the information collected gives rise to further scrutiny, the EMCDDA and Europol, in collaboration with the EMA, prepare a Joint Report and submit it to the Council and the Commission; For those emerging psychoactive substances which are judged to require further investigation, a Joint Report is drafted with the European Medicines Agency, in order to provide evidence and advice to the Council and the Commission with regard to the need for a risk assessment and control measures. A decision on the need to prepare a Joint 185 Available from: See: 5 Final Report 65

72 Report is based on criteria such as the amount of seized material; evidence of international trafficking; evidence of organised crime involvement; the toxicopharmacological properties of the substance; the potential for further (rapid) spread of the substance throughout Europe; and evidence of intoxication or fatalities. If there is strong evidence to suggest a Joint report should be carried out, Member States and the EMA are then requested to provide further updated information on the substance via a formal questionnaire sent to ENUs and NFPs. They may also consult with the EMA and the Pharmacovigilance system. The content of the Joint Report is presented in Box 2 below. Box 4: Content of a Joint Report The Joint Report should contain: A chemical and physical description of the new psychoactive substance Information on the frequency, circumstances and/or quantities in which the substance is encountered Information on the means and methods of its manufacture Information on the involvement of organised crime in the production and distribution of the substance A first indication of the risks associated with the substance, including health and social risks A first indication of the characteristics of users Confirmation whether or not the substance is being assessed, or has been assessed, under the UN system The date on which the substance was notified to the EMCDDA or Europol (date on the Reporting Form) Information on whether the substance is already subject to control measures in one or more Member States Where possible, information on the precursors used, the mode and scope of the (expected) use of the substance and other use (as well as the risks associated Three Joint Reports have been conducted since These concerned mcpp (2005), BZP (2006) and mephedrone (2009). 3) The Council may request the EMCDDA to draft a Risk Assessment on the substance Risk assessments are launched when at least a quarter of Council members, or the European Commission, is in favour. Risk assessments provide an evaluation of the potential health and social risks of the newly identified drug and the implications of placing it under control. The key elements of the report are provided in Box 3 below. The risk assessment uses the 1961 UN Convention and Article 2.4 of the 1971 UN Convention as a basis and assesses whether a new psychoactive substance is liable to similar abuse, produces similar ill effects, or is convertible into a drug as meant as the drugs in Schedule I or Schedule II of the 1961 UN Convention and is not offset by substantial therapeutic advantages or whether the new psychoactive substance has the capacity to produce a state of dependence and central nervous system stimulation or depression, resulting in hallucinations or disturbances in motor function or thinking or behaviour or perception or mood 187. Box 5: Content of a Risk Assessment report The risk assessment should contain information on: The chemical and physical description of the new psychoactive substance The health risks The social risks The level of involvement of organised crime, including information on seizures, detection and manufacture 187 See Risk Assessment Operating guidelines (2009), pp19-20 Final Report 66

73 Information on any assessment under the UN system Member State control measure, if applicable Options for control measures and their possible effects Chemical precursors used for the production of the substance As mentioned, since the adoption of Council Decision 2005/387/JHA, two riskassessments have been completed. These involved BZP and Mephedrone. Risk Assessments are conducted by the EMCDDA s Scientific Committee, which is made up of up to fifteen well-known scientists, chosen by the EMCDDA management board on the basis of their expertise and independence. These include experts in legal and criminal justice issues, risk assessment and basic research, political and institutional frameworks, epidemiology, methodological issues, best practice and interventions and economic issues. Each member serves for up to three years, although this is renewable. It is governed by an elected chair and vice-chair, who also serve three year terms (renewable). The role of Scientific Committee within the EWS is to carry out Risk Assessments. In addition, the Committee provides a formal opinion on the threeyear/annual work programmes of the EMCDDA and reviews the EMCDDA Annual report for scientific quality ) The EMCDDA submits the Risk Assessment Report to the Council and the Commission 5) the Commission may present an initiative for control measures to the Council or decide not to do so The Commission, within six weeks following the receipt of the risk assessment report, is expected to present an initiative to the Council to place a substance under control. If the Commission considers that no action is required, it will instead present a report to the Council justifying this decision, also within six weeks. 6) following the Commission's Decision, the Council may decide on the submission of the substance to control measures and on the obligation to introduce criminal law measures Following a Council Decision to submit a substance to control measures, Member States are required, within 12 months, to make the necessary changes to their national law, procedures and practices in line with the obligations of either the 1961 or the 1971 UN Conventions. They will report on the measures taken to the Council and the Commission, after which the information should also be communicated to the EMCDDA, Europol, the EMEA and the European Parliament Ineffectiveness in responding to the rapid appearance of new substances The increase in the number of substances and their complexity has posed important challenges to the Council Decision. The information exchange and notification system has worked relatively well, but the speed at which new substances emerge on the market poses challenges to the analytical capacity of the system. First, the procedures followed as part of the Council Decision require time, thus not enabling rapid action to be taken. Second, the procedure follows an individual approach, which again slows down the mechanism. Each of these issues is briefly discussed below The procedures to be followed by the Council Decision require substantial time In terms of procedures, the precise timetable set for every stage of the Council Decision is a key strength, allowing for an informed assessment of risks within a time frame of six months. If the procedures are implemented making us of their maximum time limits, a joint report can between 4-10 weeks and risk assessment up to 12 weeks to complete. Within six weeks after the receipt of a risk assessment, the Commission decides whether or not to propose control measures. The Council may then take an unspecified amount of time to decide 188 Information taken from: Final Report 67

74 whether or not to control the substance. Member States will be obliged to implement the measures up to one year after the Decision is made. However, within the current market, in which substances emerge almost every week, there is a risk it does not enable a rapid reaction to substances relevant at EU level that may pose serious risks. The procedures followed as part of the Council Decision mechanism are perceived as lengthy, also because in practice it has not always been possible to respect the time limits set by the Council Decision. The assessment showed that 17 Member States considered the decision-making procedure to be too slow. When asked about the priorities for revising the Council Decision, eight national stakeholders from a variety of sectors (law enforcement, health, NGOs) in a number of countries (AT, CY, FR, DE, LU, RO) expressed that opinion that a priority objective should be to speed up the process implemented through the Council Decision. For example, stakeholders in Cyprus and France thought the time taken to introduce control measures should be sped up. Stakeholders in Germany also suggested that assessments should be quicker to enable all Member States to respond quickly and in a coordinated manner and that EU control measures should be produced so that they could be easily and quickly implemented in MS. Another stakeholder in Belgium also stated that the EU should find a way of quickly assessing the effects in order to make consistent measures. Very often Member State already put in place national control measures before the full Council Decision procedure has been completed. Research has shown that, on average, it takes a Member State two to three months to complete a national procedure. Some Member States, such as Denmark, reported to have already put control measures in place before reporting the NPS to the EWS in Similarly, Austria, Finland, Italy and Malta put control measures in place concerning the NPS reported only slightly later that same year. Sweden was considering to regulate the NPS reported. Others put in place national control measures during the Joint Report or Risk Assessment phases. In the case of mephedrone, for example, the Risk Assessment was submitted to the European Commission and the Council of the European Union on 26 May 2010, and it then took 4.5 months (to 2 December 2010) for the Council to make its Decision to control the substance 189. By this time, however, a number of Member States had already controlled the substance under national legislation (e.g. the UK introduced control measures around 16 April 2010). The EU decision on BZP was taken 15 months after the launch of the Joint Report, while for mephedrone 12 months after. By that time, 8 and 15 Member States respectively had already taken measures at national level. As discussed above, whilst the Council Decision clearly allows Member States to legislate on NPS, these uncoordinated national decisions may create shifts in production and trade to countries that await the EU decision before acting. At the same time, for economic operators as well as for the general public, the variety of measures taken poses legal and economic uncertainty. It is also worth considering whether the national decisions were based on the same rigid scientific assessments rather than on political pressure and media hypes. In their responses to the survey, for example, 43% of the Reitox national focal points agree that the process followed through the EWS and risk assessment of the Council Decision is more robust than the mechanism in their respective Member State (and only 8% do not agree with this statement The Council Decision is based on an individual approach, addressing NPS one by one Another important point is that the Council Decision can only address one psychoactive substance at a time, through the so-called "individual approach", which aims at ensuring that a scientifically robust assessment of risks is tailored-made to each substance. However, in general, NPS tend to mimic existing, popular illicit drugs such as Cannabis and Ecstasy (MDMA) and there are a multitude of chemical molecules which can indeed create similar effects. The main families of psychoactive substances notified in the EWS are cathinones, 189 See: COUNCIL DECISION of 2 December 2010 on submitting 4-methylmethcathinone (mephedrone) to control measures (2010/759/EU), available at: Final Report 68

75 synthetic cannabinoids and phenethylamines. They emerge rapidly because they are often derived from existing (newly controlled) substances with minor modifications to the chemical composition. Their rapid emergence (and disappearance, in case users do not consider them interesting) makes it very difficult for the Council Decision mechanism to respond. Table 3.15 gives a summary of the new psychoactive substance notifications by substance type, including description of the parent compound and their representative, to illustrate the very large proportion of chemically very similar substances. Table 3.15 NPS notification by main family of the psychoactive substance ( ) Family Parent compound Representatives No. of substances notified ( ) Phenethylamines Phenethylamines (N) Amphetamine, methamphetamine, mescaline (N) MDMA, 21 Tryptamines Tryptamines (N) Psilocin and psilocybin (N), dimethyltryptamine / DMT, lysergide / LSD (S) 12 Piperazines Piperazine mcpp, BZP, TFMPP 8 Cathinones Cathinone (N) Cathinone (N), mephedrone, methylone, methcathinone (S) 26 Synthetic cannabinoids N/A the category includes a number of chemically unrelated but functionally similar families of cannabinoid receptor agonists that mimic the effects of Δ9 THC JWH-018, CP 47,497, HU-210, etc. 21 Miscellaneous substances N/A the category includes new psychoactive plants as well as synthetic psychoactive substances, derivatives of wellestablished drugs not belonging to any of the families listed above, designer medicines, narcotic analgesics, etc. N/A 27 Source: EC Staff working paper, SEC (2011) 912 Final Moreover, the "individual approach" makes it even more difficult to assess products which are composed of several substances in various combinations, such as Spice, because each of these should be considered indivually by the Council Decision mechanism (which is one of the reasons why no action has been taken at EU level on "Spice"). Along the same vein, the mechanism has not been able to respond to NPS which seek to mimic the same drug, but which are highly different in terms of chemical structure, such as cannabinoids. The synthetic cannabinoids fall into seven major structural groups including: naphthoylindoles (e.g. JWH-018, JWH-073 and JWH-398); naphthylmethylindoles; naphthoylpyrroles; naphthylmethylindenes; phenylacetylindoles (i.e. benzoylindoles, e.g. JWH-250); cyclohexylphenols (e.g. CP 47,497 and homologues of CP 47,497); classical cannabinoids (e.g. HU-210). Although these groups would need individual risk assessments if scientific fundament is maintained and decisions taken one at the time only, the response capacity overall would be improved if they were analysed and assessed as a group. What is also relevant in this regard is that users are, to some extent, following the market dynamics. For example, when asked about the consequences on their behaviour if higher controls were implemented on NPS they were using, nearly 20% indicated that they would Final Report 69

76 replace the respective substance with another one, thus counting on the fact that similar NPS existed or might appear, 11% indicated that they would seek other ways to obtain the NPS and 6% mentioned that they would actually increase their use (against, for example, 11% which would stop using the NPS). Several Member States consider that the individual approach makes the instrument slow and insufficiently reactive to market developments, preventing a comprehensive response. Indeed, as soon as a substance is submitted to control measures, a new one is often developed and marketed to replace it. To take measures on this new substance, it will then be necessary to recommence the whole procedure from the beginning. However, this 'ratrace' between authorities and producers of these substances takes place both at national and EU level and therefore does not exclusively pose problems for EU legislation Lack of information and evidence on effects and harms One of the major problems related to new psychoactive substances concerns the lack of information, forensic information and research on their potential risks and effects. Unless a substance has been used in the past for other legitimate uses (for example as medicinal product) or studied and subsequently disregarded because of unfavourable side effects, there is little or no information available on its psychoactive properties, toxicology, pharmacology and long-term effects. In the responses to the survey to national stakeholders related to the availability of information and evidence, Member States confirm that the main problems they experience in relation to NPS are: a lack of evidence on their effects on human health and wider impacts (59%), followed by a lack of capacity to monitor the emergence of NPS (36%), and a lack of evidence on involvement of criminal groups (36%) and on their economic effects (34%). When asked to comment on the state of evidence (chemical structure, toxicology, prevalence of use, immediate and long-term health effects, social effects, etc.) regarding NPS in their respective country, the majority of respondents indicated that this is poor (29%), however this was closely followed by those stating that it is reasonable (27%) and good (21%). Information is most scarce in relation to long-term health effects and prevalence, whilst toxicology and immediate health effects appear to be less problematic. Around 25% of the Member State authorities responding to the GHK survey of national stakeholders highlighted that they did not have good research capability at national level to undertake forensic and toxicology tests (against 50% indicating that they had). Even where information on clinical observations of intoxicated patients exists, the exact acute, and particularly chronic, toxicological properties of NPS are difficult to predict 190. In order to assess these toxicological properties, laboratories need to carry out analysis and, for this, they will require reference material. Reference material is also needed for absolute identification and quantification 191. However, as psychoactive substances are sold without marketing authorisation 192 this may not always exist. In some cases recycled seized drugs may be used as reference materials, if the active constituent has been isolated and adequately characterised by appropriate analytical techniques, but this seems to be rare. Without such reference materials (or even with them) it is costly and difficult to assess the toxicological properties without broad, longitudinal data. This is further complicated by the fact that some NPS have a sudden appearance and sometimes brief lifetime in the market place 193. With regard to identifying NPS, there are broadly three main types of testing for NPS (and of drugs in general), namely 1) fast testing (which is not very accurate but gives a first indication; 2) high pressure liquid chromatography (HPLC) and; 3) more advanced testing entailing e.g., nuclear magnetic resonance spectrophotometry (NMR). The third type of 190 Archer, Roland P Ric Treble, Keith Williams Reference materials for new psychoactive substances by in Drug Testing and Analysis (Special Issue: New Psychoactive Substances) vol 3:7-8 pp , July - August See EWS guidelines 192 See e.g. mcpp in the 2005 EMCDDA-Europol Annual Report on the implementation of the Council Decision 2005/387/JHA 193 Archer (2011) as above Final Report 70

77 testing, which is most thorough and rigorous, is done by experts in a handful of universities and involves very expensive machinery (the estimated costs per unit are around 150,000 EUR; in the UK, for example, there are 20 machines only). National forensic offices dealing with drug testing generally have, at best, resources to undertake testing type 2; therefore their knowledge and capacity is limited relative to universities and industry experts. Whilst the latter could be involved for law enforcement purposes, there is a risk that the chain of custody is broken when drug samples reach and are tested by universities, given that criminal law may require specific procedures to be followed to avoid subsequent allegations of tampering or misconduct. The NPS industry, especially the larger manufacturers, are also carrying out their own tests and may represent an important pool of expertise and resources which so far has remained untapped (a consultation with an industry spokesmen showed that in principle they might be willing to support testing practices by making available reference materials). As a consequence of the above, the Joint Report and also the Risk Assessment report have to use the information that is available from various sources. Such information can be incomplete or of poor quality. As a result, the Scientific Committee often has to assess a substance on the basis of imperfect and incomplete information. This lack of information poses challenges to the principle of a science-based decision-making process. The risk assessment reports on BZP and mephedrone already indicated the weak scientific basis underneath the conclusions. Furthermore, the lack of forensic and scientific capacity and knowhow also complicates the assessment of new psychoactive substances. For example, some of the synthetic cannabinoids in Spice are difficult to identify in common forensic tests, due to the lack of reference samples. And they may be masked by the addition of other substances, such as vitamins. The above has also raised on certain occasions the question why the EU does not simply follow the precautionary principle, in particular when urgent measures are needed in the face of a possible danger to human health and where scientific data do not permit a complete evaluation of the risk. This principle is applied mainly where there is a potential danger to public health. For example, it may be used to stop distribution or order withdrawal from the market of products likely to constitute a health hazard 194. The precautionary principle still requires a risk assessment as foreseen under the Council Decision. Furthermore, the general principles of risk management apply, including the principle of proportionality, consistency with similar measures taken in the past, examination of costs and benefits as well as the option to review the measures in the light of scientific developments. Given the fact that inter alia - the current Council Decision has no procedure to undertake temporary measures, and decisions to control substances entail criminalisation of the production, trade, distribution, sales but in several countries also the possession and use of these substances without possibility to review the scheduling once more evidence has become available, the precautionary principle is not well suited to tackle new psychoactive substances. Turning a large number of otherwise law abiding citizens, who are occasional or habitual users, into criminal offenders is not a decision to be taken lightly. When reviewing possible solutions to the lack of information and evidence, many survey respondents and interviewees argued for a more proactive and systematic approach to data collection, including the involvement of other stakeholders in the collection process (e.g. healthcare agencies). They also were in favour of increased information and evidence sharing. The case studies organised as part of the study confirm that forensic laboratories, for example, already to some extent share information on test results with other laboratories, but not in a systematic way and often only upon the specific request. Some laboratories are also part of networks, such as ENFSI (European Network of Forensic Science Institutes), which has the purpose of sharing knowledge, exchanging experiences and coming to mutual agreements in the field of forensic science. Stakeholders also view strong benefits in involving other types of organisations too in the exchange of information, such as health 194 P. Reuter, Options for Regulating New Psychoactive Drugs: A review of recent experiences and an analytic framework. Final Report 71

78 institutes. When discussing the potential involvement of the NPS industry in generating information and evidence, case study participants and interviewees were in general reluctant. Those that could see the advantages indicated that it would certainly require a level of oversight, to make sure that research and testing was undertaken in line with high quality procedures and standards. Finally, there may also be opportunities to collect additional information at the national level, as four Member States indicated to have more information available on NPS than what was actually currently being collected through the Council Decision. This related to more locally based information, information on drug use patterns from treatment and care systems, epidemiological research on prevalence and information on law enforcement and judicial issues Lack of monitoring of new substances and trends The majority of new psychoactive substances reported through the EWS do not become the object of a Joint Report because the criteria for triggering it are not met 195. Since 2005, even though over 200 substances have been reported to the EWS, three Joint Reports have been prepared (mcpp, BZP and mephedrone), two Risk Assessments finalised (BZP and mephedrone) 196 leading to these two substances' submission to criminal control across the EU. There are no indications that many more substances should have been brought under control at EU level, yet, as already mentioned above, at national level, in several Member States many more substances have been subjected to control measures. The Council Decision does not impose on Member States any obligation to monitor the substances notified through the EWS, or the substances that were the object of Joint Report, Risk Assessment or control measures 197. The five key indicators in the field of drug demand 198 implemented by the EMCDDA and the Member States through the Reitox Network of national focal points depend on the investments Member States make in updating these to address new challenges in the drug situation. Some Member States indeed actively monitor the emergence and market developments on NPS, but interviewees from a few Member State consider that there might be room for improvement (including Latvia, Bulgaria, Cyprus, Czech Republic, Hungary, Slovak Republic). The lack of monitoring of substances that have undergone EU level scrutiny can potentially undermine the understanding of the market (for instance, to understand the "lifetime" of a substance in the market or the effect of the control measures on a substance). Nevertheless, Member States consider that all substances that have been subject to a Joint Report, but are not submitted to risk assessment, should nonetheless be actively monitored afterwards. In addition to post-identification and assessment monitoring, the EMCDDA points at the growing need to improve Europe s capacity to monitor developments proactively and, in particular, to test and identify the chemical constituents of the product mixtures available and assess their potential impact on public health 199. One way in which substances could be proactively monitored is through test purchases. In several Member States there is some form of proactive monitoring of NPS in place, for instance via controlled test purchases or other monitoring activities, either at the national level or by individual stakeholders. For 195 Amount of seized material; evidence of international trafficking; evidence of organised crime involvement; toxicopharmacological properties of the new psychoactive substance or analogy with better-studied compounds; evidence of the potential for further (rapid) spread; evidence of intoxication or fatalities. EMCDDA, Early Warning System on New Psychoactive Substances Operating Guidelines, The EMCDDA Europol joint report on mcpp concluded that this substance seemed unlikely to establish itself as a recreational drug in its own right and recommended that, in view of the fact that the substance was used in the manufacture of at least one medicinal product, no risk assessment should be carried out. 197 The Member States are the entities responsible for the actual collection of data, which is then provided to the EMCDDA for collation and analysis through the REITOX National Focal Points. The EMCDDA does not have the mandate or the capacity to monitor new psychoactive substances on the market. 198 Drug Use in the Population (DUP), Problem Drug Use (PDU), Drug Related Deaths (DRD), Drug-Related Infectious Diseases (DRID) and Treatment Demand (TDI). 199 EMCDDA 2010 Annual Report Final Report 72

79 example, in many Member States, educational and research institutes also, as part of courses or projects, buy and test NPS. Germany, for example, has about 30 forensic institutes involved in the detection of NPS, together with the laboratories of the federal Länder. Also, as part of an EU funded project on synthetic cannabinoids is undertaking test purchasing, identification and toxicology analysis. Netherlands has the Drugs Information and Monitoring System (DIMS) managed by the Trimbos Institute collecting data directly from users, who can hand in samples of drugs that they intend to consume. This also helps in the detection of NPS. The Netherlands Forensic Institute also analyses NPS, based on samples provided by the police, including deceased persons. The two institutes exchange information and warn users. Austria has also set up a proactive monitoring system and the French National Focus Point also carries out test purchasing. However, often the results of this proactive monitoring are not shared with other relevant organisations and other Member States. This proactive monitoring of substances on the market can help to detect emerging substances and trends more quickly, before a dangerous substance is disseminated from one country to another. At the same time, there is some risk of overexposing certain substances, as the markets may strongly differ from one country to another and the proactive monitoring may potentially lead to long lists of notified substances, many of which cannot be followed in the market Lack of alternatives to control measures Currently, after the risk assessement of a specific substance is concluded, only two options are available: the Commission can decide to present a legislative proposal for submitting the substance to criminal control measures, or it can decide not to give any follow up to the report. As previously explained, submitting a new psychoactive substance to control measures can take a lenghty process that requires the adoption of a Council Decision on the basis of a Commission proposal. Therefore, although there is consensus among Member States that criminal control measures should be part of the answer, it does not seem to be always an optimal option and at any rate should not be the only one. For example, the risk assessment reports on BZP and mephedrone stated that more research was needed to ascertain their longer-term risks, since conclusive results were necessary to make evidence-based decisions. However, both substances were subjected to control measures, whilst in the meantime very little evidence has become available to confirm the harm to health of in particular BZP. This is in part because the substance stopped being monitored after the Decision was adopted by the Council, with only a few exceptions in the Member States. For example, in the Netherlands, which has a user-driven market monitoring system 200 in place, BZP was no longer found in ecstasy pills, but it has to be noted that it had never been a popular substance before the control measures were taken. On the other hand, it increasingly appears that BZP does not cause substantial harm. In fact, already in 2006 and 2007 New Zealand s Expert Advisory Commission on Drugs conducted an intensive review of the regulatory options for BZP and concluded that the risks to users were moderate. Moreover, in the UK, evidence suggest that control measures may have perverse effects 201, creating unintended consequences of prohibition, including the emergence of a criminal market (and associated violence), decrease in the quality of the product and a switch to more harmful substances. Possibly, a lighter form of risk management may enable to both tackle issues faster, for example by taking temporary measures already in the Early Warning stage if there is direct evidence of serious harm, whilst awaiting a Joint Report, possibly followed by a Risk Assessment in order to decide on permanent control measures, or possibly market restriction measures. It may also be worthwhile considering lowering the threshold for developing Joint Reports and Risk Assessments. As mentioned above, since 2005, three 200 Drug Information Monitoring System; measuring across the country the contents of pills and powders bought by consumers on the drug market; 201 J. Birdwell, J. Chapman and N. Singleton, Taking drug seriously A Demos and UK Drug Policy Commission report on legal highs, Final Report 73

80 Joint Reports 202 have been undertaken, while over 200 substances have been reported to the system. It is difficult to determine whether this is sufficient or not due to lack of exhaustive evidence on the substances and their consequences, but it is clear from the analysis above that Member States have taken control measures on a far higher share of the substances, on their own initiative. The 2011 assessment 203 shows that 14 Member States agreed that a wider range of alternative options should be considered, including temporary market restrictions during the risk assessment to facilitate the collection of information and data, and a broader range of risk management options in respect of substances that are found to pose little or no risk to health. Eighteen Member States are in favour of fast-track/emergency control measures including temporary measures while risk assessment is being carried out. Similar measures are for example available as part of the EU food safety and product safety legislation, where the precautionary principle applies 204 which allows the Commission decide, subject to strict conditions, to withdraw a product from the market for one year There are regulatory grey zones between EU instruments and inconsistencies with international instruments The limited knowledge about the chemical composition and effects of new compounds, as described above, has also facilitated the emergence of a regulatory grey area, as authorities in charge of public health or medicinal products have often failed to assume responsibility for these substances 206. In addition, NPS are often marketed as herbal medicines, food supplements, plant feeder, incense, bath salts, etc. which allows some of them to go undetected and to usurp controls on drugs. A number of other EU mechanisms exist to monitor the safety of specific products marketed in the EU, such as medicines, food and chemicals. These are: Medicines 207 The EudraVigilance system of the European Medicines Agency (EMA), which collects information on adverse drug reactions to medicines 208, including herbal medicines, registered in the EU s Member States and those authorised centrally; 202 On mcpp (2006), BZP (2007) and mephedrone (2010), with BZP and mephedrone also being followed by risk assessment and subjected to control measures. 203 This is based on evidence from the evaluation of the Council Decision: The precautionary principle is relevant in those circumstances where risk managers have identified that there are reasonable grounds for concern that an unacceptable level of risk to health exists but the supporting information and data may not be sufficiently complete to enable a comprehensive risk assessment to be made. When faced with these specific circumstances, decision makers or risk managers, may take measures or other actions to protect health based on the precautionary principle while seeking more complete scientific and other data. 205 Directive 2001/95/EC on general product safety - Article 13 and Regulation EC/178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. 206 Consideration of the Novel Psychoactive Substances ( legal highs ), Advisory Council on the Misuse of Drugs, October One of the key purposes of the UN 1961 and 1971 Conventions is to ensure the availability of psychoactive substances for medical and scientific purposes. NPS that have medicinal benefit can be placed under drug control legislation, while at the same time remain available for medicinal use. Morphine is an example of a product with a medical purpose which is highly restricted to prevent abuse. Similarly, the production of opioids for the production of medicines is licensed to a limited number of producers in a limited number of countries. The medicinal use of cannabis is a long lasting controversial issue with an increasing number of countries allowing its use and production 208 The legislation outlining the provisions of the Pharmacovigilance was amended in The relevant pieces of legislation are: Regulation (EU) No 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products; and Directive 2011/62/EU amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products Final Report 74

81 Food and animal feed - The Rapid Alert System for Food and Feed (RAS-FF), managed by DG SANCO, which collects notifications on direct or indirect risks to human health deriving from food or feed (including vitamins, minerals and food supplements) in the EU 209 ; Chemicals The Chemicals Agency (ECHA), which accepts applications on restrictions, limitations or bans on specific chemicals (following public consultation) and the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation which keeps a register of all chemicals used and imported into the EU and subjects to further evaluation and safety checks specific chemicals of concern; General product safety Rapid Alert System for dangerous consumer products (RAPEX) It allows for the rapid exchange of information between the Commission and Member States via central National Contact Points on measures taken by national authorities and/or manufacturers (e.g. temporary or permanent withdrawals or bans) to prevent or restrict the marketing or use of products posing a risk to health and safety. 210 RAPEX does not cover food, medicinal products and medical devices); Drug precursors - Council Regulation 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors. Regulation 273/2004 on drug precursors, relating to control of intra EU trade of drug precursors These instruments allow for the monitoring of the legal trade in the 23 scheduled drug precursors listed in the annexes to the regulation in view of preventing diversion of those drug precursors from the legal trade to illicit drug production. The cooperation between legal industry operators (manufacturing and trading those chemical drug precursors) and the regulatory authorities is an important element in the functioning of the EU Drug Precursor legislation; operators have to notify any suspicious transactions related to the 23 scheduled drug precursors to authorities; this obligation is extended voluntarily to the non-scheduled drug precursors on the EU voluntary monitoring list Different procedures and purposes It is important to consider that, each of the instruments discussed above has distinct processes and structures for monitoring, assessing and controlling substances and/or products. First, some of the safety mechanisms (e.g. RAPEX and Eudravigilance) are designed primarily to detect adverse that is, unexpected or undesirable reactions to products, which are supposed to be safe under normal conditions of use. For example, the product categories most frequently notified through the RAPEX system are clothing, textiles and fashion items, toys, motor vehicles, electrical appliances and childcare articles and children s equipment 211. The kinds of hazards reported include risk of injury (e.g. falling, strangulation), burns and electric shocks, choking and toxicity and/or allergic reactions from chemicals used in some toys and clothes 212. NPS are generally sold and consumed specifically for their psychoactive properties hence, the psychoactive property was expected and desired. It is thus highly unlikely that the product in question would be reported on the basis of these effects. Second, the EU mechanisms and legislation focus on products authorised within the EU, whereas NPS marketed as non-consumable products bypass authorisation laws. Where a product is authorised - e.g. a medicine - but misused for recreational purposes, it is unlikely that the product would be picked up by the above-listed mechanisms. Indeed, authorised medicines used in the EU for recreational purposes are generally reported to the EMCDDA (i.e. the EWS), rather than to the Eudravigilance system. 209 This include food bought and consumed in, or imported into the EU and can therefore relate to a single food item that has been contaminated or a whole cargo which does not meet adequate safety requirements 210 An overview of the functioning of these instruments and their involvement in / relevance to NPS is provided in Annexes 1 and See RAPEX Annual Report 2010: See RAPEX weekly reports: Final Report 75

82 Third, NPS are often marketed as unfit for human consumption which helps them to bypass food law and food safety monitoring systems 213. Similarly, although NPS tend to be chemicals, ECHA only monitors chemicals that are not designed for human consumption, and, hence, it is likely that consumption would not be considered a hazard in the case of NPS. Finally, the EU mechanisms and legislation are often limited to monitoring a set of preselected or specific substances. For example, EMA only deals with substances which are used to manufacture medicinal products which have marketing authorisation, or which are undergoing application for marketing authorisation Other potential gaps Furthermore there are some additional examples of regulatory gaps that may, in some cases, prevent control of harmful (new) psychoactive substances, namely: Where the NPS have medical value and/or are used in the processing of medicines Where the NPS, in terms of its chemical structure, is very similar to a medicine, and; Where the NPS is sold as a non-food product, or not for human consumption. In 2009, the EMCDDA, via the EWS, received reports of misuse of the prescription medicine pregabalin (marketed as Lyrica) in Finland, Sweden and Norway. Pregabalin is used to treat neuropathic pain, epilepsy and generalised anxiety disorder (GAD). User reports suggest that pregabalin is used in recreational settings, with effects similar to those of alcohol, GHB (gamma-hydroxybutyric acid) and benzodiazepines 214. There were also indications that suggested that pregabalin may have been involved in the deaths of a number of users in Finland and the United Kingdom, where it was found in forensic toxicological analyses. The EMCDDA informed the EMA, which submitted a proposal to add a warning in the section Special warnings and precautions of the Summary of Product Characteristics (SPC) of Lyrica. The Pharmacovigilance Working Group (PhVWG) will also submit a study on the long-term efficacy and safety of Lyrica in January One of the objectives of the study is to characterise the effects of pregabalin dose and treatment duration on drug discontinuation symptoms and rebound anxiety. Under the official working arrangement signed by EMA and EMCDDA in 2010, 215 data on misuse of medicines reported to the EWS is forwarded directly to EMA who then take the necessary action to reduce the likelihood of harm (either by introducing risk management procedures, such as labelling, requesting specific studies (as above) or even suspending or withdrawing products from the market 216. Whilst the potential misuse of medicinal products is usually well covered, there is a potential regulatory gap in relation to the control of harmful (new) psychoactive substances that have medical value and/or are used in the processing of medicines, according to recital 8 of Council Decision 2005/387/JHA, Substances of established and acknowledged medical value are therefore excluded from control measures based on this Decision. The Early Warning System Operating Guidelines clarify that - although not explicitly mentioned in the Decision it must be assumed that medicinal products themselves are also excluded from 213 Note EU food safety legislation covers a scope which includes all products (excepting medicines) that are intended to be, or reasonably expected to be ingested orally (see definition of food, Article 2 of Regulation (EC) No 178/2002). 214 See EMCDDA-Europol 2010 Annual report on the Implementation of Council Decision 2005/387/JHA 215 See: See Regulation (EU) No 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products; and Directive 2011/62/EU amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products Final Report 76

83 risk assessments. By analogy, this applies to veterinary medicinal products as well 217. Indeed, the Memorandum of Understanding signed between the EMCDDA and EMA in 2010 states that Cooperation between EMCDDA to EMA on risk assessment of new psychoactive substances under the Council Decision 2005/387/JHA shall pay particular attention to ensure that no deterioration of either human or veterinary health care as a result of this Decision will be permitted... Moreover, Article 7(3) of the Council Decision specifies that no risk assessment shall be carried out on a new psychoactive substance where the substance is used to manufacture medicinal products which have marketing authorisation, or which are undergoing application for marketing authorisation (taking into account that the supply chain of medicinal products including their intermediates is already very strictly regulated and controlled). According to the EWS Operating Guidelines, this provision should be interpreted to refer to an intermediate in the production of an active pharmaceutical ingredient as well as an active pharmaceutical ingredient used to manufacture a medicinal product. However, the situation is complicated due to the fact that it is actually difficult for the EMA to identify whether or not a substance has been used in the manufacture of a medicine (including veterinary medicines) or not, as the agency, nor Member States, hold information on substances used in the synthesis of its registered medicines, and such information can be obtained only at a late date, if at all. In the case of mcpp, the information on the manufacturing uses of the substance was established via the Mutual Recognition Facilitation Group (MRFG). The Mutual Recognition Facilitation Group (MRFG) forms part of the Coordination Group for Mutual Recognition and Decentralised Procedures of the Heads of Medicines Agency. The MRFG responds to need to coordinate and facilitate the operation of the decentralised mutual recognition procedure, which is the main method of licensing of medicinal products through the European single system 218. Also, it is not clear whether EU pharmaco-vigilance systems and related legislation can deal with NPS which are chemically very similar, but not identical in terms of chemical structure, to authorised medicinal products and which aim to mimic their effects. Finally, the EWS also receives reports, and subsequently monitors and sends out risk alerts on adulterants found in controlled drugs. The 2007 Implementation Report notes that on a few occasions in 2007, the EMCDDA issued public health-relevant warnings to the Reitox network concerning adulterants found in controlled drugs e.g. glass beads found in cannabis, atropine-adulterated cocaine, and lead-poisoned cannabis Council Decision s interrelationship with international systems Annex 1 of this current Report outlines the role of other international instruments in monitoring and regulating new psychoactive substances. Within the Council Decision there are a number of Articles (2, 5, 6 and 7) which make reference to coherence of the Council Decision with UN instruments. The purpose of these provisions is to prevent overlap of activities (i.e. assessments) and duplication of efforts between the systems. For example, Article 2 stipulates that the scope of the Council Decision applies only to substances which are currently not listed under the schedules of the 1961 UN Single Convention on Narcotic Drugs 219 and the 1971 Convention on Psychotropic Substances 220. Article 5.2(e) of the Council Decision requires the Europol-EMCDDA Joint Report to include information on whether or not a new substance is currently under assessment, or has been under assessment by the UN system ; Articles 6 states that the risk assessment report should include information on any assessment of the substance in the United Nations system among others; and Article 7 states that no risk assessment will be carried out under the instrument in the instances when the new psychoactive substance concerned is at an 217 EWS Operating Guidelines, p.19. Available at: See also: EMCDDA-Europol 2006 Annual Report on the implementation of the Council Decision 2005/387/JHA, p See: for more information Final Report 77

84 advanced stage of assessment within the United Nations system (i.e. when the WHO expert committee on drug dependence has published its critical review together with a written recommendation) or if the new psychoactive substance has been assessed within the United Nations system, but it has been decided not to schedule it under the 1961 or 1971 conventions. Indeed, in 2010 during the risk assessment of mephedrone, in accordance with Article 5.2(e), the EMCDDA verified first with the UN whether mephedrone was already undergoing assessment through its system. In comparison with the Council Decision, the UN system tends to be lengthier and heavier than the EMCDDA s system. Within the EU system, the Expert Committee on Drug Dependence (ECDD) of the World Health Organisation (WHO) is tasked with carrying out medical and scientific evaluations of the potential for abuse of drugs falling within the terms of the 1961 and 1971 Conventions and for making recommendations on whether or not to include emerging substances to the two Conventions through publication of a critical review together with a written recommendation. However, this is a relatively lengthy procedure and the UN has a lack of resources to carry out these reviews hence they rely on the EU and the Council Decision in this regard. For example, in 2008 elements of the EWS were presented to the United Nations Office on Drugs and Crime (UNODC), as part of the process informing the implementation of the UN s Global synthetics monitoring: analyses reporting and trends (SMART) programme 221. In introducing potential changes to the current Council Decision, there may be some value in reconsidering the link with the UN system. In relation to the use of the 1961 and 1971 UN conventions within the scope of the Decision, EU officials from various DGs and agencies consulted as part of this study expressed the overriding view that the reference to the UN conventions is appropriate, as they ensure that duplication of efforts is avoided and that they also provide a useful starting point. The majority of the sixteen responding Reitox NFPs and one Europol NU (98%) also either agreed or strongly agreed that that it was appropriate that the scope of the Council Decision covers substances not included in the schedule of the 1961 and 1971 UN Conventions. Only two responding NFPs (CZ, DE) stated that they neither agreed nor disagreed. 3.6 The baseline scenario The current legislation is not flexible enough to tackle the new challenges and lacks rapid as well as intelligent / sensible options to address a complex phenomenon. If there would be no changes made to the current instruments at EU level some of the problems described in the previous sections will continue and potentially get worse Trends in demand will continue in line with availability which is likely to increase The level of demand for NPS differs from Member State to Member State; however, in general, demand is dependent on the specific success of a particular product (i.e. whether it becomes popular or not), as well as the characteristics of supply (i.e. high accessibility, low price). In addition, as supply of NPS increases (see below) it is reasonable to assume that this may also lead to an increase in the demand, because of availability. Demand will also affected by factors such as legislation / control; publicity i.e. media coverage; and the availability of good quality illicit substances with a similar effect to the NPS. Overall, the demand for NPS is likely to continue, and to increase in the future, in line with the supply. Users take NPS primarily for their effects, and the demand and appeal of certain psychoactive substances, which are perceived to have better effects than others, has rapidly increased in some Member States over the past few years. Notable examples are Spice and mephedrone, which are two of the most popular psychoactive substances respectively in Germany and in the UK. In Germany, the lifetime prevalence of use among teenagers in Frankfurt of spice and spice-like mixtures was 9% in 2010, rising from 6% in 2008 and 7% 221 See EMCDDA-Europol 2008 Annual Implementation Report on the Council Decision 2005/387/JHA Final Report 78

85 in In addition, 2% of the Frankfurt youth had used spice and spice-like mixtures during the past month, an increase of 1% in comparison to the year before 223, while lifetime prevalence of use for the country as a whole was 0.8% in year. 224 In the UK, mephedrone which used to be so popular as a legal high that a control measure had to be implemented in 2010 is still reported as used by 1.4% of people aged in Moreover, judging by the use of mephedrone, the consumption of which as a controlled drug is as high as ecstasy, it could be foreseen that the popularity, appeal and use of certain psychoactive substances will undoubtedly persist in the future. As new psychoactive substances are placed on the market it can be expected that, amongst them, specific substances will be singled out for particular popularity and increasing demand. In said earlier, consumption of NPS is also driven by the supply (high levels of availability, coupled with a low price) of the products. As demonstrated in Figures 3.8 and 3.10, supplyrelated factors such as availability, variation in products, and low price are significant factors in young people trying NPS, as also demonstrated in national studies. 226 The fact that psychoactive substances were easily available through legal channels (61%) was the third most common motivation for the use of psychoactive substances among young users in Germany. 227 The 2010 ban of head shops in Poland eradicating the physical sale of psychoactive substances, for example, has led to a certain reduction in the availability, and henceforth use, of such substances. By and large it is expected that new psychoactive substances will continue to emerge and be available on the market (see section 3.3). Currently, there is notable variation between Member States in the extent to which there is a demand for NPS, and some countries exhibit relatively low prevalence of use rates, such as Spain (0,7%) and Germany (1,8%), or the Netherlands where psychoactive substances are largely not perceived as a problem at all. In part, this seems to be related to the availability of other, illicit substances. It is however plausible to assume however that Member States with lower consumption patterns may in the future exhibit higher prevalence of use rates, particularly if certain substances strongly appealing to consumers emerge on the market. Legality is another factor affecting demand: 43% of users surveyed (see Figure 3.8) stated that they used NPS, at least in part, as a substitute for illicit substances. Furthermore, 28% of users surveyed (29 respondents see Figure 3.10) described legality as a benefit of NPS. Indeed NPS are frequently marketed e.g. on online stores - as alternatives to illicit substances and users of cannabis, 228 cocaine 229 and other illicit substances are amongst those using NPS such as spice and mephedrone. To the extent that the sale of NPS producing similar effects to illicit substances remains legal, there will continue to be a demand from users who seek these effects without undertaking an illegal act. Once a substance is subjected to control measures, supply of that substance may also decrease. 222 Werse, B (2009) Spice, Smoke, Sense & Co. Herbal Mixtures Containing Cannabinoids: Use and Motivation for Use against the Backdrop of Changing Laws Federal Ministry of Health - Division 125: Addiction and Drugs, commissioned by Goethe-Universität Frankfurt a.m., FB 04, Centre for Drug Research. Available at: Idem. 224 Idem. 225 See Home Office Statistical Bulletin: Drug Misuse Declared: Findings from the 2010/1British Crime Survey Available at: J. Birdwell, J. Chapman and N. Singleton, Taking drug seriously A Demos and UK Drug Policy Commission report on legal highs. 227 Idem. 228 Werse, B (2009) Spice, Smoke, Sense & Co. Herbal Mixtures Containing Cannabinoids: Use and Motivation for Use against the Backdrop of Changing Laws Federal Ministry of Health - Division 125: Addiction and Drugs, commissioned by Goethe-Universität Frankfurt a.m., FB 04, Centre for Drug Research. Summary of results and methodology available from: 31_Drogenbeauftragte.pdf 229 This was reported by a UK stakeholder to the national stakeholder online survey. Final Report 79

86 For this reason also, users may turn to legal alternatives, which may be more widely available. Overall, given that it is estimated that over 5.8 million young people in the EU Member States (aged would have tried NPS in their lifetime at least once, a proportion of which is likely to use such substances more or less frequently, the potential profits to be made are large. This figure excludes users in other age groups meaning that the segment of users will be a bit larger, making supply highly profitable Trends in supply will continue and are likely to increase Magnitude and dynamics of supply The supply of new psychoactive substances has rapidly increased since the introduction of the Council Decision. Between 2005 and 2011, 164 new psychoactive substances have been identified, with the numbers of notifications having increased from 14 in 2005 to 49 in Given the on-going trend since 2005, it is very likely that new psychoactive substances will continue to emerge at an increasing pace. In the first two months of 2012 alone, 14 new substances were notified to the EMCDDA, which if extrapolated could result in almost a doubling of new substances in 2012 compared to If the situation remains unchanged, and on the basis of the trend registered during the period , the number of annual notifications of new substances through the EWS is expected to increase to approximately 103 in , which would represent circa a 110% increase from 2011 to This would result in high number of new psychoactive substances being supplied. Although not all of them would develop onto specific products in the market, as many of the new psychoactive substances are try-outs in the market with their success depending on the user demand and control measures, it is plausible to assume that a larger supply of products in the market would also lead to an overall increase in the overall size of the market. With the estimated current value of the NPS market at 4 billion, it is estimated that by 2020 the value of the market would increase up to 8.4 billion, assuming that the market value grows in line with the projected increase in the detection of new psychoactive substances. The current supply is primarily focussed on three main groups of substances, the most popular groups in terms of volume of supply being synthetic cannabinoids, followed by cathinones and phenethylamines. In the future this is likely to change, with new groups of substances also potentially emerging on the market, as suppliers circumvent controls on established substances by switching to the supply of (new) substances that have not be banned. It is difficult to predict in advance which families of substances these are likely to be. However, considering the fact that a high number of substances (several thousands) can potentially be manufactured and synthesised with low cost with potentially high profit margin, the supply will continue to grow, possibly in multiple groups of substances. The overall increase in supply is also supported by the fact that outlets selling these substances are easily accessible (i.e. via the internet). Indeed, the Internet which is also the main channel through which purchasers import new psychoactive substances in the Member States, has witnessed a sharp increase in the number of online shops selling these products during the last years. The number of online shops operating in the EU identified by the EMCDDA internet snapshot survey 232 increased from 170 in January 2010 to 314 one year later to 631 in July This growth rate 230 The projection for assumes linear trend and has been calculated using the line of best fit as the equation function. 231 Evidence from literature also supports the hypothesis that the number of new psychoactive substances is likely to increase in the future: it is generally accepted that the supply of such substances will most certainly continue to grow. See: P. Reuter, Options for Regulating New Psychoactive Drugs: A review of recent experiences and an analytic framework. 232 EMCDDA, Online sales of new psychoactive substances / 'legal highs': summary results from the 2011 multilingual snapshots, Final Report 80

87 represents an average increase of about 90% 233 per annum over the period. While national legislation on the sale of NPS as a whole (such as that in Poland) is likely also to affect sale by Internet in some cases meaning that some European online shops may be closed down, 234 new online stores based in third countries are likely to open with sales to the EU. For example, around a third of the shops identified in July 2011(197 of 631) were based in the United States of America. By contrast, specialised shops like head shops are unlikely to grow in the future. Although head shops exist in various Member States (Bulgaria, Germany, UK) and some Member States (Czech Republic) have witnessed an increase in the number of specialised shops selling new psychoactive substances in recent years, more Member States (e.g. Ireland, Poland, Romania) have seen a decrease in the number of head shops due to legislation restricting sale of NPS; a decrease has also been reported in the Netherlands. The decline of head shops in some Member States is also likely to boost supply via the Internet as proprietors of physical shops switch to sale online. The manufacture of NPS is relatively low cost, in part this is due to the low price of precursors evidenced, for example, by the fact that those selling illicit substances have often cut their products with NPS (or passed off NPS as illicit substances) in order to increase their profit margins. As identified in Table 2.1, the cost of purchase of the substances over the internet is between1 through to 45 euro; although most were in the 4 to 20 euro price range, with the price also being dependent on volume. One NPS supplier company manufacturing and selling around 20 products reported an average annual turnover of around 1m euro with a profit margin of around 50% The effect of existing and in train policy interventions is likely to be relatively small Recently over a third of EU Member States [AT, BG, CY, FI, HU, IE, LT, PL, RO, SE, UK] have modified their national legislative framework as a response to the emergence of new psychoactive substances and at least two [DK, LU] are planning to do so in the future. These changes have addressed the approach taken to controlling substances, moving from an individual to a generic or analogue approach (AT, BG, CY, DK, HU, LT), the robustness/efficiency with which control decisions can be taken (FI); the elimination of market for NPS (IE, PL, RO); and the temporary banning (UK) or complete restriction (LU, SE) of substances that are harmful to health. No immediate additional future legislative changes are planned in the Member States, although Member States such as Finland and Germany are considering potential future changes to increase the effectiveness of their current measures through control of groups of substances. Overall, the policy interventions have had some effect, but considerable shortcomings in the EU as whole pertain. At national level control measures have had some effect in reducing demand and supply. For example, following the control of mephedrone (4-methylmethcathinone) and related cathinones in the UK, the emergency department patients with acute toxicity related to the use of mephedrone had a significant fall following the control of mephedrone. This suggests that the control of mephedrone in the United Kingdom may have been effective in reducing 233 (In the calculation the figure 631 was considered as if it was the end year figure. If this would not be the case, the average increase over the period per annum is 214%). Between January 2010 to January 2011, the number of online shops operating in the EU identified by the EMCDDA internet snapshot survey increased by about 85% from 170 to 314. In the subsequent year the growth rate was about 100% and the number of online shops operating in the EU increased to 631. Based on the available statistics mentioned above, the growth rate of online shops operating in the EU is expected to be about 90% per annum. 234 SEC(2011) 912. See also UK Case Study online shops selling NPS were closed through cooperation with Internet Service Providers in the UK in Final Report 81

88 the acute harm associated with the drug. 235 Similarly, following the control of MVDP in Finland, seizures of the substance have been significantly reduced as well as the associated harm following the reduction in the use of this substance, including in the associated poisonings and deaths 236. However, the current situation will continue in which substances that at first sight seem to pose serious risks to the health and safety from an EU level perspective, cannot be addressed very rapidly in the EU as whole, creating imbalances of supply and demand in the EU. As previously seen with mephedrone, Member States are forced to act instantly as a result of public pressure and media exposure and take independent decisions of variable nature on the risk management and control of such substances, possibly leading to important differences between the Member States. These disjointed control measures on penalising production/sale/use are likely to increase perverse effects on such measures in the EU as a whole. Possible outcomes are likely to include: NCP shopping whereby users travel to another Member State to take advantage of more lenient legislation in other Member States. This was common, until recently, in the Netherlands where tourists from other Member States travel there to consume cannabis and magic mushrooms. Differences in legislation on NPS may create an imbalance in burdens on the healthcare systems of different Member States, where Member States with more lenient legislation have to treat more patients from other Member States consuming NPS on the territory. For example, following the introduction of legislation specifically less hospital emergencies among tourists in Amsterdam decreased 237. Relocation of NPS retailers to Member States with less lenient legislation. For example, following the introduction of legislation restricting the sale of NPS through head shops in Poland, over 30 head shops shifted location to the Czech Republic. It has been argued that casual or new users are more likely to head shops to purchase NPS than the Internet and that the closure of such shops has a greater impact on such user types than on more established users. 238 As Member States introduce inconsistent legislation on the retail of NPS this may create islands of head shop friendly Member States that could witness rises in the supply and (new) use of NPS. Where Member States are inconsistent in their regulation of NPS this would have consequences for the EU as a whole. As customs between Member States are not checked 239, this would allow NPS to be sent freely to those Member States with stricter legislation to those with less strict regulation. Hence, inaction in one Member State could easily filter to others. The lack of coordination at the EU level will also result in continued legal uncertainty for companies. The examples of crackdowns by national authorities on "head shops" in various countries show that often these came unexpected. Some shops were reopened after it had been established that they did not sell any new psychoactive substances that had been made illicit. This will continue and may cause losses to companies that may suddenly find themselves left with stocks of illicit substances. In addition, the continued legal uncertainly is likely to lead into situations in which companies supplying new psychoactive substances and consumers alike are in risk of inadvertently breaching the legislation due to variability of 235 Woode, Greene & Dargan (2011) Short report: Emergency department presentations in determining the effectiveness of drug control in the United Kingdom Emergency Medicine Journal This information is based on stakeholder consultation. In 2010, 33 poisonings three deaths were confirmed relate to the use of MVDP. As a result of the control, these have been reduced. See also Finnish article: Lapatto- Reiniluoto, O et.al (2011) Design ylettyy jo huumeisiinkin, Suomen Laakarilehti 16-17/2011 vsk See online national stakeholder survey. Following the ban the use of a substitute (sclerotia, philosopher s stones) became more popular. 238 NACD (2011) Head Report: An Overview of New Psychoactive Substances and the Outlets Supplying Them 239 With the exception of few Member States. For example, the Finnish Customs actively search NPS to monitor their supply to the country. However, this activity is not undertaken in most Member States as it is very costly. Final Report 82

89 control measures across the EU. In particular, consumers may not be aware that a substance that is legal in one Member State is not in another, and as a consequence possibly face severe penalties for the breach of legislation. At national level, as described, legislation will continue to be introduced as and when it is perceived to be required by the national situation, and there may be opportunity to introduce innovative or alternative means of regulating NPS, e.g. through market authorisations combined restrictions, such as those currently considered in New Zealand. For substances that cause concern at EU level there will still be no choice than to leave them on the market unregulated or to make them subject to drug control measures. This lack of regulatory options may fuel a 'rat race' between authorities and the market, one in which authorities at national and EU level simply re-label the legal status of new psychoactive substances from 'unregulated' to 'controlled', creating long lists of prohibited, complex chemical substances which can only be identified in specialised laboratories, leaving the issues of the production of new replacement (and potentially more dangerous) substances unregulated Consequent harm is likely to increase, even if not extensively As set out in section 2.2.3, the cost of current harm relating to NPS is estimated at 0.5 billion per annum. Assuming that the level of harm will increase in line with the assumed growth in supply, by 2020 the value of harm is estimated at 1.1 billion. The harms associated with the use of new psychoactive substances can take different forms such as physical or psychological harm and social harm, which are associated with socio-economic costs. On the basis of increased supply and a demand which is more or less based on availability, as well as ineffectiveness of some of the current control measures, it can be assumed that physical or psychological harm as well as social harm associated with new psychoactive substances will increase. Although anecdotal evidence 240 suggests that, to some extent, new substances which produce high levels of harm often do not establish themselves on the market, there is also growing evidence to demonstrate harms associated with NPS (see section 3.3.7). Most of the information available on the harms of NPS relates to more established/popular substances (which have now been mostly controlled), such as GBL, mephedrone, ketamine and Spice. This demonstrates a relationship between the scale/extent of use and the scale/extent of harm that occurs. In line with this, it is probable that as newer psychoactive substances become more established (e.g. MXE in the UK), the harm associated with these substances will become more evident. This is even more so given the current ineffective intervention measures which do not address the risks stemming from mis-labelling of products and insufficient information as to dosage, usage (i.e. whether the substance can be consumed with others such as alcohol or not) and potential harms. The results of forensic analysis have shown that products marketed under the same brand names often contain varying chemicals. Without an onus on retail and industry to ensure that the products meet certain safety standards and correct information, this risk to health will continue and, as NPS gain popularity and new substances are produced, may even increase. As new psychoactive substances with unidentified, but potential harms continue to be sold on the legal market unregulated, users who would be otherwise deterred from trying the products were they controlled/restricted will continue to be exposed to risks to their health, who would not otherwise be were the substances controlled. It is plausible that health problems are likely to increase in the future, in line with the increasing number of NPS in the market and their availability and appeal to users. In addition, the use of new psychoactive substances may also increase anti-social and (to a lesser extent) criminal behaviour in individuals under the influence of such substances. As the demand for NPS continues, anti-social behaviour associated with this is likely to be 240 Information on the harms associated with NPS is scarce in comparison with other psychoactive substances such as alcohol, tobacco and illicit substances Final Report 83

90 driven by substance dependence, sickness, personality changes, altered perceptions which have been reported as effects of some NPS. Use of NPS is also likely to be increasingly linked to productivity losses at work / university / school and to disruptions to social networks which can lead to other social problems. Although there is little systematic research into the links between criminality and use of NPS, anecdotal evidence suggests that users of NPS may be less likely to resort to criminal activities to pay for their use of NPS first because NPS tend to be much cheaper and easily available than illicit drugs, and users tend to be in employment or otherwise affluent enough to pay for them. Conversely, increased EU control measures may increase criminality and associated harm if they push substances onto the illicit market, as illicit substances tend to cost more than legal ones, which risks increasing the likelihood of crime to fund the purchase of the substances. As mentioned in section 3.3.3, there are a number of ways in which organised crime can have a role in the production and supply of NPS 241. The involvement of OGC is likely to increase in some contexts, but remain the same in others. For example, the involvement of organised crime in the manufacture is currently limited to some substances and some activities only and is likely to continue to be the case. By contrast, the involvement of organised crime in the sale of still-legal NPS may increase, but most likely only if a particular substance gains substantial popularity prior to control (as was the case for mephedrone in various EU countries) - such a trend is difficult to predict. However, as more substances are submitted to control measures under drug control legislation, rather than through alternative regulatory options (e.g. market regulation), the involvement of organised crime in the sale of recently controlled NPS is likely to increase. Indeed, as more NPS are submitted to control this is likely to increase the market potential for the illicit market, particularly when the substance has already gained popularity amongst users who are willing to risk breaking the law by buying the substance illegally in order to have access to the substance. Moreover, continued prohibition of large numbers of new psychoactive substances coupled with an increase in market potential for the same substances on the black market may push legitimate market operators underground increasing the number of actors involved in illegal or criminal activity. Similarly, if the current situation continues in certain Member States in which citizens, often young people, can face arrest and prosecution when caught when using or in the possession of one of the many new psychoactive substances that may be scheduled under drug laws. In many Member States, this can have immediate repercussions such as fines and even custodial sentences 242, but also later on in life, among others because of the fact that criminal records may be drawn up which may affect later careers. 3.7 Right to act and subsidiarity Principle of conferral The EU's competence to act stems from its obligation to ensure a high level of health, safety and consumer protection in its proposals for the establishment and functioning of the internet market (Article 114(3) TFEU) and "a high level of human health protection in the definition and implementation of all Union policies and activities" (Article 168(1) TFEU). 241 These were: In the manufacture of NPS (e.g. tableting); In the sale of still-legal NPS In the sale of recently controlled NPS In the sale of NPS disguised as illicit substances. 242 Criminal sanctions on possession are applicable in at least the following Member States: BE, BG, CZ, DK, FI, FR, DE, GR, IE, LT, LI, MT, RO, SE and UK. Administrative sanctions on possession are applicable in CZ, FI, LV and SI. 243 Please note that the information provided in this section regarding the principle of conferral and the subsidiarity principle has been obtained from the Commission s preliminary IA Report. Final Report 84

91 Currently, new psychoactive substances are manufactured and traded in a regulatory grey area, in a legal vacuum between drug control, food safety, consumer protection, medicines and chemicals legislation. This legal vacuum has enabled an increasing number of unregulated and potentially harmful substances to emerge: over the past two years, a new psychoactive substance has emerged, was marketed and sold every week. Many such substances are marketed and sold over the internet, which makes national regulations on market restrictions ineffective. There exist substantial differences between the Member States' laws, regulations and administrative provisions dealing with such products. These discrepancies have adverse effects on the marketing of certain legitimate substances and on public health. They impede the proper functioning of the internal market, create uncertainty as to potential health and commercial risks, and affect public health by allowing potentially harmful products to cross borders and spread across the EU. Such barriers to legitimate trade and risks to public health should consequently be eliminated. Rules relating to the assessment of new psychoactive substances and restrictions applying to those that are considered harmful should be approximated, while leaving Member States the possibility of introducing, under certain conditions, additional requirements that they consider necessary in order to guarantee the protection of the health of individuals. While approximating Member States' legislation and administrative action relating to the assessment, marketing and sale of new psychoactive substances, the proposed instrument will take as a base a high level of health protection. Article 168(1) TFEU gives the EU the competence to complement national policies by acting "towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health". Such action shall cover, among others, "early warning of and combating serious cross-border threats to health". Unregulated new psychoactive substances may pose harms to the physical and mental health of individuals in several Member States. Those new psychoactive substances that have the potential to cause severe risk to health and safety would be declared illicit and submitted to drug control legislation. In the latter respect, the EU also has the competence to establish minimum rules concerning the definition of offences and sanctions in the areas of particularly serious crime with a cross-border dimension, including illicit drug trafficking (Article 83(1) TFEU). This article also gives the EU the competence to enact measures necessary to list harmful new psychoactive substances as illicit drugs across the EU and to submit the trafficking in these substances to minimum EU-wide rules Respect of the subsidiarity principle Being an area of shared competence, the Union should take action only if and in so far as the objective cannot be sufficiently achieved by the Member States ("necessity test") and that it can be better achieved by the Union ("EU value added test"). (i) Necessity test Member States are unable, individually, to address effectively and sustainably the rapid spread of new psychoactive substances. National controls are difficult to enforce, since these substances can be transported freely in the internal market. They are often sold over the internet, which makes national control measures ineffective. In addition, national decisions on psychoactive substances can have knock-on effects on other countries' drugs situation, as they may give rise to displacement effects. Geographical displacement occurs when the production, distribution or sale of new psychoactive substances are relocated to countries that have lower control measures in place. While for many years specialised shops selling new psychoactive substances existed in only a few Member States, in the past two years such shops have opened up at a rapid pace in several countries, including Poland, Ireland and Romania. There is no common approach across the EU with regard to the regulation of these specialised shops. Nevertheless, national decisions on these shops, as well as on internet sales, can have knock-on effects on other Member States' policies. Final Report 85

92 Examples of knock-on effects Recent interventions by the Polish authorities on over 1,300 head shops in the country have resulted in traders opening similar shops in neighbouring Czech Republic. A similar dynamic has been observed between Sweden and Norway, with substances regulated in Sweden moving to the market in Norway. Differences in national legislation may lead to 'consumer tourism'. They can also lead to problems in cross-border law enforcement and judicial cooperation. Member States are affected differently by new psychoactive substances. While the UK, Ireland, Poland, Sweden and Romania have recently experienced a massive increase in the availability of these substances, others, like France or the Czech Republic, have been less affected by this phenomenon. Some new psychoactive substances are a local problem, but others, like BZP and mephedrone, spread across the EU very rapidly. (ii) EU value added test The EU should address those new psychoactive substances that are a problem across the EU, while Member States should tackle substances whose use or potential harms are confined to the local or national level. A new psychoactive substance should be considered a problem at the EU level in at least one of the following situations subsists: 1) it is detected in a large number of Member States; 2) it poses particular harm or social risks; 3) there is evidence that organised crime is involved in its production or distribution. Final Report 86

93 4 Policy objectives This section describes the policy objectives for possible action at EU level. The policy options presented in Section 5 will be assessed against the specific objectives. Table 4.1 below presents the outline of the policy objectives as agreed at interim reporting stage. The table also includes the specific objectives as used by the Commission in the impact assessment, showing the linkages. Table 4.1 Policy objectives General objectives Specific objectives Commission specific objectives Operational objectives To reduce the potential adverse consequences of new psychoactive substances on the health, safety and quality of life of EU citizens To prevent and/ or reduce adverse and unintended consequences of responding to and controlling the phenomenon of new psychoactive substances To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful new psychoactive substances To better account for, and where possible, regulate the market dynamics of new psychoactive substances To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To improve the capacity to rapidly identify and assess harmful new psychoactive substances, and withdraw them from the market if necessary To reduce the availability of harmful new psychoactive substances and the negative consequences on consumers' health and safety, and on society. To better anticipate and address the possible perverse / displacement effects of control measures To improve coordination and consistency between national systems in place To improve coordination and close gaps and loopholes with other EU risk management and monitoring relevant systems To reduce the number of harmful substances emerging / existing on the market To improve knowledge about appeal, effects toxicology, epidemiology, prevalence and crime associated with new substances To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies To improve consistency between national responses to harmful new psychoactive substances that are a crossborder problem. To reduce the risk of displacement of harmful new psychoactive between the Member States. To avoid that restriction measures on substances impede future legitimate uses of these substances. To increase the mechanism s capacity to anticipate emerging threats To improve the efficiency of the current mechanism and reduce the length of the overall procedure and its specific phases To improve post-risk assessment monitoring To develop alternative risk management options, between no action and control measures To improve the coverage of the current mechanism, making it more responsive to the dynamics of the market in new psychoactive substances that aim to circumvent regulation and control measures Final Report 87

94 5 Elaboration of policy options This section includes brief descriptions of each policy options considered as part of this impact assessment study. Apart from the Status Quo and the Zero option (i.e. Discontinuing EU action), the options have been organised around eight different clusters, namely: Cluster 1: Preparing to allow (some) NPS on the market Cluster 2: Basic elements Cluster 3: Improving Early Warning System and Joint Report procedures Cluster 4: Research and analytical capacities on new psychoactive substances Cluster 5: Addressing new psychoactive substances individually or in a group Cluster 6: Temporary emergency measures Cluster 7: Final decision on a new psychoactive substance Cluster 8: Education and awareness-raising Some of the titles of policy options within the clusters have been coloured. The dark green shading indicates that these options have been fully assessed, including the quantification of their impacts as they were considered priority options by the Commission. The options highlighted in light green are additional options for which GHK has undertaken the quantification of the economic impacts. The quantification of economic impacts has been submitted separately as an Annex (Annex 8) in Excel format to the Commission. 5.1 Status Quo No changes to the current situation. Each cluster includes a short description of the relevant elements of the Status Quo. 5.2 Discontinue the Council Decision Some information and exchange continued on the basis of EMCDDA recast regulation. 5.3 Cluster 1: Preparing to allow (some) NPS on the market This cluster includes several options which would pave the way for allowing some NPS to be legitimately produced, distrusted, sold and used, using a similar approach as the one taken for alcohol. This would require considering what would be an acceptable level of harm (again, similar to alcohol), assessing whether the harm of a substance can be effectively mitigated through prohibition and possible displacement effects of such, and the effects of possible alternative approaches Policy option Establishment of an EU reference list on harms associated with licit and illicit psychoactive substances This would include regular assessment and updating of the risks and effects of licit and illicit psychoactive substances, also for reference purposes for new psychoactive substances. Over time, a reference list of more or less harmful substances is created, and when information on certain new psychoactive substances is obtained, these can be included in the list. The reference list is relevant for comparison between psychoactive substances but also to inform the public about risks and develop prevention approaches. It would support the development of appropriate control (criminal justice) and market regulation measures, as well as prevention measures Policy option 1.2 Risk assessments by industry Under this option, the production, distribution and sales of new psychoactive substances could be allowed, provided that the industry can prove that they are safe for human Final Report 88

95 consumption, thus creating a categorisation or class of substances which can be legitimately traded, accompanied by various market restriction measures to further ensure their safe use. This would require, for example, a clinical trial and other types of research (e.g. similar to cosmetic testing) which would show that they would not be harmful to health, nor have harmful social effects. It would also require, possibly, new legislative mechanisms for such authorisations and it is unclear if this policy option can be introduced at EU level Policy option 1.3 Market authorisation with restrictions The EU, following the risk assessment, would authorise the production, distribution and sale of the substance, but decide on possible market restriction measures to ensure safe consumption of the substance. These could include: Conditional access: requirement for (proper) labelling and packaging of products, e.g. child proof containers, health warnings, recommended dosages, etc. Placing conditions on marketing and sale, e.g. related to the age of purchase, the places of sale (e.g. pharmacies, not close to schools, etc.), no marketing through the provision of free samples, no sales by persons convicted of drug-related offences. Putting in place thresholds on active components Price controls and taxes. 5.4 Cluster 2: Basic elements Status Quo The Council Decision would benefit from clear and common definitions, to also close the gap between different types of EU legislation, so that all NPS which are not identified as medicine, food, chemical or illicit drugs are covered. In the current situation, some NPS risk going undetected as they are not picked up by any of the EU mechanisms, including the Council Decision on NPS, the pharmaco-vigilance systems and the food safety mechanisms Policy option Introduction of common definitions Introduction of a definition of new psychoactive substances and legal highs, which should close the gaps between different types of EU legislation so that all psychoactive substances that are not identified as medicine, food, chemical or illicit drugs are covered (e.g. bath salt which has the clear intention to be used as a drug) Policy option Improved coordination and referral to other EU legislation / mechanisms This proposal would include increased coordination and referrals within the legal instruments to other relevant EU legislation / mechanisms, during pre-risk assessment stage. This concerns for example the food safety mechanism run by EFSA and the pharmaco-vigilance system run by EMA. The main purpose would be to ensure that new psychoactive substances are swiftly detected in the supply chain and to avoid that these are not considered by any of the existing mechanisms. In addition, the proposal would help to identify other EU legislative instruments which could possibly be used in order to control new psychoactive substances. In addition to possibly making legislative changes to the Council Decision, the option could be accompanied by practical guidelines, memoranda of understanding, etc. 5.5 Cluster 3: Improving Early Warning System and Joint Report procedures Status quo In the current situation, there are some procedural issues which may cause delays when the need arises to prepare a Joint Report. In addition, the Early Warning System could benefit from additional details, where these are available, in order to allow for fast decision-making on the need to produce a Joint Report and possibly take emergency measures. Final Report 89

96 5.5.2 Policy option 3.1 Improved conditions for Early Warning System (EWS) Member States would be required, where possible, to share more information as soon as they notify (or re-notify) a substance through the EWS, including information on their chemical structure, toxicology, prevalence of use, health effects, etc Policy option 3.2 Joint Report to include early toxic screen The Joint Report would already include a first screening of the substance on toxicology. This would also allow for the launching of the urgency procedure (see also Cluster 6 below) Policy option 3.3: Improved conditions for Joint Reports: Decision powers regarding Joint Reports The Commission, in addition to the Council, EMCDDA and Europol could also request a Joint Report. 5.6 Cluster 4: Research and analytical capacities on new psychoactive substances Status quo The research and analytical capacities on new psychoactive substances at the EU level are currently limited. When a new psychoactive substance is detected in a Member State, national authorities submit information on its composition and expected or reported effects, if available, to the EMCDDA and Europol through the EWS. Scientific information and evidence on the properties, effects and risks of a substance lacks very often. There is currently no possibility to conduct forensic, toxicology and pharmacological research at the EU level at short notice. In addition, epidemiological data from population surveys (e.g. prevalence, use patterns, emergency room data) lacks as well. The EU agencies currently collate and analyse available at national level, when available, but this provides an insufficient basis for assessing the actual risks of substances. Furthermore, the current lack of consistency between national regulatory regimes on new psychoactive substances undermines the exchange of reference samples. Finally, the current system does not include systematic proactive monitoring, nor does it monitor the extent to which NPS, which were the subject of a risk assessment but for which no action was taken, are still appearing on the market and causing harm Policy option 4.1 Development of common criteria and guidelines for proactive monitoring Specific criteria and methodological guidelines would be developed for the proactive monitoring of new psychoactive substances (possibly followed by the introduction of a proactive monitoring system under the intermediate approach). These would help the Reitox network members and Europol National Units to undertake any proactive monitoring according to common procedures and criteria, which substances to select for further examination (e.g. thresholds), etc. The current monitoring system used by EMCDDA could be further elaborated for this purpose Policy option 4.2 Introduction of a proactive monitoring system This option would set up a proactive monitoring system to anticipate emerging threats, which would include the identification, test-purchasing, synthesising and studying of new compounds Policy option Introduction of a post-risk assessment monitoring system This option would introduce a monitoring and follow-up system specifically for substances which were the subject of a risk assessment report, but for which no control measures were taken. The monitoring would focus on the potential need to add new evidence related to recent developments and additional knowledge to the risk assessment, to allow for a reassessment of the need to introduce control measures. Final Report 90

97 5.6.5 Policy option 4.4- Introduce additional standardised tools and databases for risk assessments This proposal would introduce additional common methods, tools and instruments for risk assessments, especially concerning new psychoactive substances for which very little scientific on their effects is available. With respect to prevalence studies, this would, for example, include the development of standard sets of survey questions (which require a minimum of adaptation to tailor it to a different substance) for surveys to users and organisations working with potential users. The proposal could also include the development of a common, EU wide database of young people and relevant organisations in the field, who are in principle willing to respond to surveys (e.g. similar to the European Business Test Panel), so that risk assessments can involve a large group of respondents within a relatively limited time period Policy option Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA Under this option, the EU's research and analytical capacity on new psychoactive substances would be improved. Its capacity to produce rapidly forensic, toxicological and pharmacological data on new psychoactive substances, to support and strengthen the collection of information on the potential harms of a substance and assess its risks, would be enhanced. This would be done by supporting structural collaboration of European research institutions (including the Joint Research Centre JRC), in coordination with the EMCDDA, and promote cooperation between the EMCDDA and forensic laboratories' networks, such as the European Network of Forensic Science Institutes. This would facilitate the development and sharing of forensic information and research findings on new psychoactive substances. This network would also support the development of systems to collect epidemiological data (including the standardisation of survey methodologies, protocols and data collection methods), help disseminate information (including on prevention) and reassess the harms of substances. It would help to develop common EU criteria and guidelines for the proactive monitoring of the market (internet monitoring, test-purchasing), which national authorities will be invited to implement voluntarily Policy option Establishment of an EU research laboratory for new psychoactive substances This option entails the permanent expansion of EU research capacity in this field by establishing laboratory functions in one identified research facility (JRC) or EU Agency (EMCDDA). This laboratory may have the same functions as mentioned under the previous policy option, allowing the assessment and on-going monitoring of the availability of specific substances at the EU level. 5.7 Cluster 5: Addressing new psychoactive substances individually or in a group Individual approach (status quo) The Council Decision is based on monitoring, notification, risk assessment and decisionmaking on individual substances. This means that each substance is risk assessed taking into account its specific properties, effects and potential harms. A decision on it is made on the basis of the identified harms. Currently, it is possible to assess individual substances in parallel, but a risk assessment report would then be produced for each substance. A separate Council Decision would be necessary for submitting each such substance to control. Certain Member States pursue assessment and decision-making approaches that tackle groups of chemically related substances together, without assessing the individual properties, effects and risks of substances within the group. Decisions are based on their Final Report 91

98 similarity in chemical structure (generic approach) or on the similar pharmacological effect (analogue approach) Policy option Generic approach by group of substances This option would allow for assessing the risks and making decisions on several new psychoactive substances at the same time, based on their similar chemical structure. The risk assessment could start with an individual substance, and when appropriate also considering their generic context, providing, where possible, for an intelligent grouping of substances (i.e. reviewing the possible emergence of chemically related substances and their anticipated risks). But since substances that are chemically similar can have very different effects and pose different risks, the generic risk assessment would in practice mean assessing the risks of one substance and extrapolating results to a group of related substances (without assessing their particular risks) Policy option Analogue approach by group of substances This option would allow for assessing the risks and making decisions on several new psychoactive substances at the same time, based on their similar pharmacological effect. This could in particular apply to groups of substances which mimic the same drug (e.g. the synthetic cannabinoids imitating cannabis) that separately may not warrant a risk assessment to be undertaken but as a group cause an EU-wide concern. With the analogue approach substances that may not even have psychoactive effect or that pose no harm could be prohibited as well. 5.8 Cluster 6: Temporary emergency measures No temporary emergency measures (status quo) The existing mechanism does not foresee at any stage of the procedure the possibility to introduce temporary emergency measures across the EU to restrict production, trade and sale of a new psychoactive substance that may cause immediate concerns. No decision is taken on a substance at the EU level until definitive measures are adopted, following a risk assessment. Even if the current procedure under the Council Decision has strict timetables, it took 12 months until the decision to submit mephedrone to control measures was adopted by the Council. In the case of BZP, this took 15 months Policy option Urgency Joint Report procedure for toxic substances As part of the Early Warning System, specific criteria would be developed to activate an urgency procedure for preparing a Joint Report for new substances which appear to have a high level of toxicity and / or on which initial reports on adverse health consequences raise particular concerns in several Member States Policy option EU recommendation to introduce temporary emergency measures On the basis of the results of the joint report produced by the EMCDDA and Europol, the Commission can recommend to the Member States to introduce emergency measures to restrict the production, trade and sale of a new psychoactive substance that poses immediate concerns. This measure only concerns the use of the substance for its psychoactive effect; it will not restrict its availability for research and legitimate industrial uses. If the risk assessment shows that the substance poses severe risks, the emergency measures will be made definitive by scheduling the substance on a restricted substances list. The purpose of the measure is to ensure that the substance can be assessed thoroughly without consumers being exposed to its potential harms until its actual risks are identified. The emergency measures should have a limited duration (maximum one year, renewable once) and should automatically expire after that time. Final Report 92

99 5.8.4 Policy option EU decision to introduce temporary emergency measures Same as above, but the temporary emergency measures will be binding on Member States. To ensure rapidity of action, this decision will be taken through a delegated act Policy option 6.4 Extending of Risk Assessment period during temporary restriction The temporary restriction measure of a harmful new substance, would allow for more time for the Risk Assessment to explore in detail its harm. 5.9 Cluster 7: Final decision on a new psychoactive substance EU decision to submit substances to criminal law control measures or do nothing (status quo) Under the Council Decision, on the basis of the risk assessment, the Commission can either table a legislative proposal requiring Member States to submit the substance to criminal law control measures (under national illicit drugs legislation), or justify why this is not necessary Policy option EU decision to submit substance to criminal law control measures or to recommend permanent market restriction measures Under this scenario, once the risk assessment is concluded, the EU would have different alternatives for action. If the risk assessment proves that a new psychoactive substance poses severe risks to health and safety of individuals, the Commission can decide to add the substance to a list of substances submitted to criminal control measures across the EU (by means of a delegated act). However, if the risk assessment proves that a new psychoactive substance has a moderate or low risk to health and safety, the Commission can recommend to the Member States to introduce market measures permanently restricting the production, trade and sale of the new psychoactive substance, without restricting availability for research and legitimate industrial uses (by means of a delegated act. If the Commission decides that no further measures are necessary, it should justify why. Possible market restriction measures could include: Permanent market restriction prohibiting import / export Permanent market restriction, prohibiting manufacture, production, trade, distribution and sale Possible control measures could include: Permanent control, making import/export, manufacture production, trade, distribution and sale a criminal offence Permanent control making possession an offence. The above measures would not restrict the availability of new psychoactive substances for research and legitimate industrial uses Policy option 7.2 EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures Same as above, but the permanent market restriction and control measures will be binding on Member States Policy option EU prescribing the measure and outcome of control and risk management Same as above, but EU would prescribe the type of control and market restriction measures to be implemented by the Member States (in addition, their desired outcome). Both the implementation measures and outcomes would be prescribed by the EU. The option would be binding and would entirely harmonise approaches across the Member States Final Report 93

100 5.10 Cluster 8: Education and awareness-raising Status Quo In the current situation, there is a continued misconception amongst many users that, because of the fact that they are (semi-)legally sold and marketed, NPS are also safe. In addition, it is difficult to find reliable information on NPS, as in several Member States this is not available through public channels and because the information contained on the packaging of NPS is often incorrect. Whilst some NPS may indeed be relatively safe, others are potentially very harmful. There is therefore a growing need for information, education and awareness-raising Policy option Educational and awareness-raising activities Additional activities to make users aware of the risks associated with new psychoactive substances. This would include evidence-based drug prevention measures, including the provision of objective and factual information, awareness-raising about potential risks of using new psychoactive substances, even when these are sold legally, or with a specific focus on certain substances Policy option Awareness raising and guidelines for better monitoring on import of NPS in the EU This proposal would include developing EU-wide awareness raising activities and guidelines for Customs officials in the Member States (and targeted Third Countries) to make these authorities aware of the importance of notifying new psychoactive substances. In addition, these activities could be extended to relevant companies, e.g. couriers and private postal services, transport firms etc. Final Report 94

101 6 Assessment of the policy options 6.1 Introduction This Section of the Report presents qualitative assessments of each of the identified policy options with regard to their achievement of the policy objectives, their economic and social impacts, impacts on fundamental rights, unintended impacts and the practicability / feasibility and acceptability of the policy options. The following sub sections presents the individual assessments of the policy options following the clusters as set out in Section 5. The scale used for the ratings is shown in the table below Symbol Explanation +++ High positive impact ++ Medium positive impact + Low positive impact 0 No impact - Low negative impact -- Medium negative impact --- High negative impact 6.2 Status Quo Status Quo No changes to the current situation. Each cluster presented above includes a short description of the relevant elements of the Status Quo. Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk Key anticipated impacts Whilst the current EU mechanism has a good scientific base and capacity to deal 0 with NPS, the instrument shows some shortcomings. For example, it would strongly benefit from clear and common definitions so that all substances which are not identified as medicine, food, chemical or illicit drugs are covered within its scope, improved forensic, toxicology and pharmacological capacity, systematic proactive monitoring, a post-risk assessment system, increased capacity to undertake research on NPS, etc. The current EU mechanism to a certain extent limits the availability of harmful 0 NPS and prevents/ reduces their negative health effects through the introduction of criminal control measures. Nevertheless, it is important to ensure that measures are proportionate to the risks posed by NPS, hence the current instrument would strongly benefit from having an alternative approach to dealing with certain NPS (e.g. temporary or permanent market restriction measures). As above. 0 Whilst contributing to better accounting for and regulating the NPS market to a certain extent, the current functioning of the EU mechanism is reactive and the control measures take some time before they can be implemented. As mentioned above, an alternative approach to criminal control is desirable in order to allow responding to NPS causing various degrees of harm proportionately and avoid triggering perverse market dynamics (e.g. fast appearance of other, possibly more harmful NPS when substances are placed under control etc.). Rating 0 Final Report 95

102 To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies At present, several Member States take measures before a decision at the EU level has been reached (or in the absence of any such decision) concerning NPS. In addition, some Member States implement control measures, following an EU decision, with a substantial delay. Both issues cause market distortion and displacement effects. Currently some NPS risk going undetected as they are not picked up by any of the EU mechanisms (e.g. Council Decision, pharmaco-vigilance system, food safety mechanism etc.). Total rating score Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases There are some budgetary consequences to the EU budget and to the Member States budget, At EU level the contribution relates to all aspects of the running of the Council Decision and at Member States level providing contributions primarily through the EWS. There are no budgetary consequences for industry. Indirect costs primarily relate to law enforcement costs and costs to judicial authorities following prosecutions. This is as a consequence of banning two NPS under the Council Decision (BZP and mephedrone). On average one substance has been every three years since 2005 (e.g. BZP in 2007 and mephedrone in 2010) 0 0 Economic effects indirect costs In the status quo the value of harm is estimated at around half a billion euro per 0 reductions / benefits annum Total 0 Social impacts Positive effects The availability of potentially harmful substances is being restricted in the EU, 0 which contributes to some reduction of social costs associated with the use of NPS, including physical and psychological harms (toxicity and overdosing, dependency, fatality etc.). Negative effects Control measures, especially when disproportionate, might lead to increased 0 criminalisation of especially young people. Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Some enhanced consumer protection (Article 38), as harmful NPS are removed from the market. As Member States take different approaches to criminal sanctions, Article 49 on the principles of legality and proportionality of criminal offences and penalties might be negatively affected in some instances where a harsher approach to criminalisation is chosen. The current control measures might provide for an increase in the black market, a decrease in the quality of psychoactive substances and increased criminalisation of users, as well as displacement effects to third countries where such measures do not apply. Practicability / feasibility Not applicable. 0 Acceptability Member States agree on the need to update the Council Decision, to be able to better respond to the dynamic nature of the NPS market and to address some of the shortcoming identified in relation to the current mechanism. 0 The political acceptability of the measure has weakened over the past few years due to the need to upgrade the system in line with the dynamic nature of the NPS market. The measure should reduce the availability of such substances by offering different ways of dealing with them, rather than one outcome only. The industry has reservations on the current control measures, hence it would be important to seek a more proportionate response to the most harmful NPS. Total Final Report 96

103 6.3 Discontinue the Council Decision Discontinue the Council Decision Some information and exchange continued on the basis of EMCDDA recast regulation. Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Key anticipated impacts Discontinuing the Council Decision would have a high negative impact on the overall response to the issue of new psychoactive substances. Based on the Recast regulation of December 2006, some information and exchange will continue to take place between EMCDDA and the Reitox network. In particular, the NFPs will provide information on new trends in the use of existing psychoactive substances and/ or new combinations of such substances that pose a potential risk to public health, as well as information on possible measures in this field. However, the EU would not have the specific scientific capacity to undertake risk assessment of NPS, or the necessary legal base to submit harmful substances to criminal control measures. As above limited information and exchange would take place between EMCDDA and NFPs on the new trends in the use of existing or new NPS, but it is not clear how the EU would respond to potentially harmful substances, if lacking significant scientific and response capacity. This would have a negative impact on the prevention of the potential risks to public health caused by NPS. Similar to the above the only difference is that in addition to health, the negative impact would affect the economy and society at large. No impact 0 Medium negative impact: Member States would have different approaches to -- tackling NPS, without the possibility of an overarching EU response applicable to all in the case of harmful NPS. Moreover, the lack of an EU risk assessment would deepen the unintended effects caused by differences in approaches to NPS between Member States because there would be limited understanding of the harm which might be caused by certain substances in a cross-border context/ market. No impact 0 Total rating score 8- Rating Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits Negligible running and administrative costs to the EU and MS budgets, with a 0 higher dependence on information supplied by Member States and human resources necessary at this level. No impact identified 0 No impact identified 0 Total 0 Social impacts Positive effects No impact identified 0 Negative effects No impact identified 0 Total Final Report 97

104 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Indirectly, this option would have a negative impact on consumer protection (Art 38) as the EU would not have the scientific capacity to identify and risk assess NPS and their negative consequences to public health, nor the credibility or legality to undertake appropriate action in this area. Greater differences in approaches to tackling NPS between Member States are expected, which would in turn increase the risk of unintended cross-border negative impacts (e.g. displacement effects). Practicability / feasibility This option is not practical, especially given the current dynamic nature of the NPS --- market in Europe, as well as internationally and the need for governments and society to act rapidly to prevent any potential harm caused by NPS. Acceptability Similarly to the above, the acceptability of the option is likely to be very low. --- Total Cluster 1: Preparing to allow (some) NPS on the market As indicated in section 5, the following policy options were included within the Cluster 1: Policy Option 1: Establishment of EU drugs reference list risk classification system Policy Option 2: Risk assessments by industry Policy Option 3: Market authorisation with restrictions The assessments of these policy options are presented in Table 6.16 to Table 6.18 below. Table 6.1 Establishment of EU illicit risk classification system (PO 1.1) Policy option 1.1 Establishment of EU reference list of harms associated with licit and illicit psychoactive substances This would include regular assessment and updating of the risks and effects of licit and illicit psychoactive substances, also for reference purposes for new psychoactive substances. Over time, a reference list of harms of more or less harmful substances is created, and when information on certain new psychoactive substances is obtained, these can be included in the system. The system is relevant for comparison between psychoactive substances but also to inform the public about risks and develop prevention approaches. It would support the development of appropriate control (criminal justice) and market regulation measures, as well as prevention measures. Key assessment Key anticipated impacts criteria Rating Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful Medium positive impact. The option would allow for the mechanism to categorise NPS and come forward with a response which is proportionate to the risk they pose, thus improving its effectiveness. Medium positive impact. A proper reference list of harms would help to 'dimension' new psychoactive substances, categorising them according to their level of harm. It could have a preventative function as it would, to some extent, draw users' attention to substances which are highly harmful - and possibly deter them from consuming them - and those which represent less harm. Medium positive impact. A proper reference list of harms would allow users to be better informed about the risks, thus contributing to the prevention of economic, health and social costs Final Report 98

105 new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Small positive impact as the reference list s would categorise substances by their level of potential harm and hence assist in making more informed decisions as to whether NPS should be subjected to EU wide control measures (either through market restriction or criminal control measures) or not. However, impact on market dynamics would be limited, as Member States may still take national level measures independently. Small positive impact provided that Member States adopt the EU reference list on harms and agree to make national level decisions also on the basis of the reference list. No impact identified 0 Total rating score 8+ Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits Small to medium negative effect. At EU level, the set-up would include the - development benchmarks for harms / risks in order to create the reference list. This would most likely need to be done through quite an extensive study, which would also look at similar existing reference lists. The reference list of harms should be updated on a regular basis to review whether the existing harm indexing should be revisited and new psychoactive substances added to the list. This may either require specific research (expressed in days or studies) or by mapping and making use of other recent research and studies. In terms of administrative costs, some training on the system would be required for EU officials. Member States would incur costs for the implementation of the system, mainly related to information inputs to allow for the categorisation. Some training would need to be provided to relevant stakeholders, for example law enforcement and judicial authorities. No impacts identified 0 Potentially positive, but highly indirect and conditional effect. The reference list of harms would allow the EU to take more appropriate market restriction and control measures, as well as strongly help to inform users on the risks of substances. This would, indirectly, lead to cost reductions in healthcare and other social costs. On the condition once more that appropriate market restriction measures are taken, law enforcement / judicial costs may be reduced somewhat as a result of more targeted control measures. Total 1 - Social impacts Positive effects Positive social impacts would include reduced physical and psychological 0 harm, due to users being better informed about the risks and harms of new psychoactive substances. However, no direct link to harm reduction can be established. Negative effects None identified 0 Total 0 Final Report

106 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Some positive impact on the freedom to conduct a business (Art 16), as the option would index harmful and less harmful new psychoactive substances, which may lead to decisions to not impose control measures on less harmful NPS, also at the level of Member States. The option would also enhance consumer protection (Article 38), as consumers would be better informed about the risks that NPS represent and the reference list of harms may move NPS within the area of consumer protection. Finally, the EU reference list of harms may enhance principles of legality and proportionality of criminal offences and penalties (Art 49), as criminalisation of using NPS may be reduced. 0 Unintended impacts No impact identified 0 Other considerations Practicability / feasibility Acceptability The practicability of the option is good, as the EU reference list of harms would help to take appropriate prevention, market restriction and control measures. Creating such list and keeping it up-to-date is also feasible. The political acceptability of the option is high. The lack of information regarding the harms of NPS is one of the major issues in fully understanding their impacts. A reference list would be very helpful development in this regard. As already mentioned, the reference list would also assist in decisions regarding possible control measures and the types of control measures to be undertaken. Total Table 6.2 Risk assessments by industry (PO 1.2) Policy option 1.2 Risk assessments by industry Under this option, the production, distribution and sales of new psychoactive substances could be allowed, provided that the industry can prove that they are safe for human consumption, thus creating a categorisation or class of substances which can be legitimately traded, accompanied by various market restriction measures to further ensure their safe use. This would require, for example, a clinical trial and other types of research (e.g. similar to cosmetic testing) which would show that they would not be harmful to health, nor have harmful social effects. It would also require, possibly, new legislative mechanisms for such authorisations and it is unclear if this policy option can be introduced at EU level. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances High positive impact. By requiring industry to undertake risk assessments on NPS they wish to market, the mechanism will be greatly supported in identifying which NPS are emerging (as industry will inform them of their intention to undertake a risk assessment) and are, at least by industry, potentially considered safe. The mechanism could thus concentrate on those NPS which appear harmful and which emerge on the market without industry expressing the intention to subject them to a risk assessment, making them also potentially more suspicious (businesses may have already considered that these NPS would not pass a risk assessment). Medium positive impact. NPS which are considered economically interesting by industry will be subjected to a risk assessment, which would strongly help to reduce the potential harmful effects of NPS. However, firstly, it would be essential to agree on a common approach to risk assessments to be undertaken by industry and both the implementation and the outcomes of risk assessments would need to be tightly controlled, through a verification and validation system managed by the EU with inputs from national stakeholders. Second, there is a persisting risk that some part of industry, especially those who could not afford to undertake risk assessments, would continue trading Final Report

107 NPS as they currently do, i.e. by mislabelling them, indicating that they are not for human consumption, etc. To reduce the As above, whilst overall, the impact would be positive, there is a persisting risk ++ economic, health of economic, health and social costs generated by harmful NPS as these will and social costs not disappear from the market altogether. generated by harmful new psychoactive substances To better account Medium positive impact. As indicated above, by requiring industry to undertake ++ for, and where risk assessments on NPS they wish to market, the mechanism will be greatly necessary, regulate the market dynamics of new psychoactive supported in identifying which NPS are emerging (as industry will inform them of their intention to undertake a risk assessment) and are, at least by industry, potentially considered safe. Market dynamics will be regulated by allowing some NPS to be legally traded whilst banning more harmful ones. However, substances in a part of the semi-legal and illegal market will continue to exist as not all traders way proportionate will be willing / able to undertake risk assessments. to the risk To avoid and/ or reduce unintended effects caused by The risk assessments as such would not diminish possible unintended effects, but indirectly, differences in approaches to NPS by Member States would be reduced as some level of harmonisation would occur. + differences in approaches to new psychoactive substances between Member States To eliminate No impact identified. + regulatory grey zones between EU instruments and increase synergies Total rating score 11+ Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits Industry claims that around 2 NPS per week appear on the market, i.e. 104 per year. Of these, it could be assumed that industry would consider 25% worth assessing (the rest they know is of poor quality). Hence it could be assumed that the EU would have to verify / validate 26 risk assessments per year and issue market authorisations and restrictions. At EU level, costs would need to be incurred for setting up a common risk assessment approach to be used by industry and to develop verification and validation systems to approve risk assessments by industry. In terms of running costs, these would relate to the need to monitor risk assessments and their outcomes and for verifying and validating risk assessments by industry, as well as costs related to issuing market authorisations / rejections. There would be some administrative costs for the delivery of training to EU officials to familiarise themselves with the process Member States may incur costs if they are asked to contribute to verification and validation of risk assessments especially if the industrial stakeholder is based in their Member States. Some training to relevant civil servants to familiarise themselves with the process would also be required in that case. Costs to industry may vary greatly, depending on the requirements put in place by the EU on the risk assessment approach. The unit cost of a risk assessment could vary between several thousand euros for a simple test to several millions if a full clinical trial is required. For the purpose of the impact assessment, an average cost per risk assessment of 100,000 has been applied. Some companies may not be able to afford risk assessments. They could either stop their commercial activity or decide to remain in the illegal or semilegal market (e.g. selling substances as 'not for human consumption). Indirect costs reductions may occur, but only in case market authorisation is obtained following a risk assessment, as discussed under policy option 1.3 below. Estimated harm reduction: 0% Final Report 101

108 Total 3 - Social impacts Positive effects Indirect positive impact may occur, but only in case market authorisation is 0 obtained following a risk assessment, as discussed under policy option 1.3 below. Negative effects No impact identified 0 Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Some positive impact on the freedom to conduct a business (Art 16), as the option may ultimately allow for businesses to legitimately trade substances which are considered to represent an acceptable level of harm. The option would also enhance consumer protection (Article 38), as risk assessments would show the possible harmful effects of NPS and if, in the longer term, consumers could purchase NPS legally (and hence protected by consumer safety laws, etc.). + No impact identified 0 Other considerations Practicability / feasibility Acceptability The practicability and feasibility of the policy option is questionable. On the one hand, part of industry is already engaged in testing their products and would be willing to undertake risk assessments. On the other hand, it can be expected that another part would not be interested in undertaking risk assessment, either for commercial reasons or because of a lack of capacity. It may also be difficult to monitor compliance of businesses with the risk assessment requirements and procedure, as well as verify and validate the results. The acceptability of the policy option is very low, as several Member States would be very much against it. However, although some experts could perceive the benefits of such an approach, as well as part of industry, it is unlikely that it would be acceptable to range of stakeholders. Total Table 6.3 Market authorisation with restrictions (PO 1.3) Policy option 1.3 Market authorisation with restrictions The EU, following the risk assessment, would authorise the production, distribution and sale of the substance, but decide on possible market restriction measures to ensure safe consumption of the substance. These could include: - Conditional access: requirement for (proper) labelling and packaging of products, e.g. child proof containers, health warnings, recommended dosages, etc. - Placing conditions on marketing and sale, e.g. related to the age of purchase, the places of sale (e.g. pharmacies, not close to schools, etc.), no marketing through the provision of free samples, no sales by persons convicted of drug-related offences. - Putting in place thresholds on active components - Price controls and taxes. The above would be similar to the model proposed in New Zealand. Key assessment Key anticipated impacts criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS Medium positive impact. The option would allow the mechanism to suggest an adequate to NPS which are considered less harmful, proportionate to the risk they pose. This would improve the effectiveness of the system. Rating ++ Final Report 102

109 To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances Medium positive impact. The option would allow the marketing of NPS which are considered to represent an acceptable level of harm, whilst placing clear restrictions on marketing and sales. Users would also be better informed about, for example, the recommended dosage and potential contraindications. Moreover, the quality of the substance would be subject to monitoring, which would also help prevent the NPS including any other (and possibly more harmful) ingredients than those allowed. There is, however, a persisting risk that some part of industry would continue trading NPS as they currently do, i.e. by mislabelling them, indicating that they are not for human consumption, etc. As above. Overall, the impact would be positive, also because it would allow for some NPS to be legitimately purchased, reducing criminalisation of mainly young people. There is a persisting risk of economic, health and social costs generated by harmful NPS as these will not disappear from the market altogether. To reduce the ++ economic, health and social costs generated by harmful new psychoactive substances To better account High positive impact. By using market authorisation, part of the current grey +++ for, and where market will become much more transparent, as a large part of industry would necessary, regulate have a vested interest in having their products authorised. Market dynamics the market will be improved by regulating NPS in a way which is proportionate to the risk dynamics of new they pose, by allowing some NPS to be legally traded whilst banning more psychoactive harmful ones. substances in a way proportionate to the risk To avoid and/ or High positive impact, as some NPS, which are considered to represent an +++ reduce unintended acceptable level of harm would be allowed on the market and be properly effects caused by regulated. This would reduce the possibility that more harmful analogues may differences in appear on the market following a ban. The involvement of criminal groups in the approaches to new production of the NPS would also be reduced. psychoactive However, there is a risk that an authorised NPS would also be accompanied by substances some negative effects, like those similar to alcohol (e.g. binge drinking, between Member addiction). States To eliminate No impact identified. + regulatory grey zones between EU instruments and increase synergies Total rating score Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) At EU level, costs would be incurred for setting up the authorisation system, including the procedure, the thresholds, etc. The EU would also incur running costs for authorising sales. This may include consultation with, as a minimum, the MS in which the NPS company is based - more likely however all MS should be involved in agreeing on the authorisation of an NPS. In terms of administrative costs, the EU would need to issue guidelines and provide training of those responsible for the authorisation process Member States would also incur costs for setting up control procedures. To the extent that they would be involved in the authorisation process, they would incur running costs for their inputs. Administrative costs would be incurred for guidelines and training of those involved in the authorisation process and responsible for controlling For the Member States, there will also be direct income / revenue if taxes are charged. It is estimated that the scale of the market of two, popular NPS could represent approximately 10% of the current scale of the market (i.e. 400 million euro), which, when taking a tax rate of 10%, would amount to 40million. Industry would incur costs for lodging the authorisation request Compliance costs would also be associated with implementing the market restriction measures, related to packaging and labelling, production standards, - - Final Report 103

110 Economic effects indirect cost increases Economic effects indirect costs reductions / benefits marketing rules, etc. Industry may also have to pay some taxes, although it is likely that most are directly charged to consumers. Member States would need to allocate responsibilities to administrative or other authorities for checking (e.g. controls) whether a NPS, once authorised, is sold in line with the market restriction requirements. Reduced indirect costs for law enforcement, as certain NPS will be allowed, rather than law enforcement having to enforce control measures, investigate, etc. Reduced indirect costs for judicial authorities, due to reduced prosecutions and cases going to trial The legal market for NPS may become big businesses. It is likely that bigger players will move in (why not pharmaceutical companies for example) and smaller companies being pushed out of the market Possibly a reduction in the variety of NPS, as less replacement substances would be produced in response to bans Estimated harm reduction: 5% Total 1 - Social impacts Positive effects Positive social impacts would include reduced physical and psychological ++ harm as users would have access to a legal and safe substance. Also reduced criminalisation of in particular young people. Negative effects Some negative effects may occur, similar to those related to alcohol (e.g. - binge drinking, addiction), especially when a NPS becomes popular, which would have negative effects on health and possibly lead to productivity losses. Total +1 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Practicability / feasibility Acceptability Some positive impact on the freedom to conduct a business (Art 16), as the option may ultimately allow for businesses to legitimately trade substances which are considered to represent an acceptable level of harm. The option would also enhance consumer protection (Article 38), as consumers would have access to a product which is considered to be safe whilst at the same time be protected consumer safety laws, etc No impact identified 0 The feasibility of the policy option is low. First, it would be necessary to adopt a common concept of what constitutes an acceptable level of harm. It is unlikely that Member States will agree on this. Second, Member States would need to agree that some NPS can be legally traded, which again is unlikely. The practicability of the option is good, as the EU could set up a market authorisation process, this could be based on approaches taken for alcohol, tobacco, etc. The acceptability of the policy option is low, as most Member States would oppose the proposal. However, several experts could perceive the benefits of such an approach, as well as part of industry. Total Cluster 2: Basic elements As indicated in section 5, the following policy options were included within the Cluster 2: Policy Option 2.1 Introduction of common definitions Policy Option Improved coordination and referral to other EU legislation/mechanism The assessments of these policy options are presented in Table 6.4 and Table 6.5 below. Final Report 104

111 Table 6.4 Introduction of common definitions (PO 2.1) Policy option 2.1 Introduction of common definitions Introduction of a definition of new psychoactive substances and legal highs, which should close the gaps between different types of EU legislation so that all psychoactive substances that are not identified as medicine, food, chemical or illicit drugs are covered (e.g. bath salt which has the clear intention to be used as a drug). Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Some positive impact. Introduction of a comprehensive definition of new psychoactive substances describing what related terms such as legal highs, research chemicals, etc. will contribute to a better common understanding amongst those involved in the mechanism, as well as help to identify whether substances fall under the drug or other systems. Negligible impact, indirectly common, more precise definitions would improve decision making on NPS. As above. 0 Some positive impact. Indirectly, more precise definitions related to NPS used by all Member States could contribute to an improved understanding and regulation of the market and its dynamics. Some positive impact, as common definitions as part of the EU instrument could also harmonise Member State national terminology and understanding of NPS, which might further align national approaches, thus reducing unintended and displacement effects. Medium positive impact, as definitions related to NPS would help to reduce the gaps between the different types of EU instruments which might be relevant for dealing with these substances (e.g. EU illicit drug legislation, EMA pharmacovigilance system, EFSA food safety mechanism etc.) Economic impacts Final Report 105

112 Policy option 2.1 Introduction of common definitions Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Negligible one-off set-up cost at EU level, which would include a review of suitable existing definitions (e.g. used by other Member States and in third countries), as well as the drafting of the EU definitions, discussion and their final elaboration. Minimum set-up costs might be involved in some Member States transposition of the new definition in the national legislation, if required i.e. if the EU definition differs from the national one. No impact identified 0 Economic effects indirect cost increases Economic effects No impact identified 0 indirect costs reductions / benefits Total 1- Social impacts Positive effects Some positive impact, as a common definition of psychoactive substances + would generally improve the focus and strengthen the functioning of the EU and national mechanisms, thus indirectly generating more positive social impacts. Negative effects No impact identified 0 Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Indirectly, a definition of NPS would strengthen consumer protection (Art 38) as there might be better understanding of the problems related to NPS (e.g. legal does not mean safe ) and associated risks to health/ society etc. - + None identified 0 Other considerations Practicability / feasibility Whilst stakeholders overall are in favour of establishing common EU definitions, the development of these may encounter some difficulties, considering the great current differences in definitions and interpretations. It might be very challenging to reach consensus. Acceptability Overall, Member States are in favour of developing common definitions. ++ Total 3+ + Table 6.5 Improved coordination and referral to other EU legislation/mechanism (PO 2.2) Policy option 2.2 Improved coordination and referral to other EU legislation / mechanism This proposal would include increased coordination and referrals within the legal instruments to other relevant EU legislation / mechanisms, during pre-risk assessment stage. This concerns for example the food safety mechanism run by EFSA and the pharmaco-vigilance system run by EMA. The main purpose would be to ensure that new psychoactive substances are swiftly detected in the supply chain and to avoid that these are not considered by any of the existing mechanisms. In addition, the proposal would help to identify other EU legislative instruments which could possibly be used in order to control new psychoactive substances. In addition to possibly making legislative changes to the Council Decision, the option could be accompanied by practical guidelines, memoranda of understanding, etc. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current Medium positive impact. Better coordination and referral of new psychoactive substances between the relevant EU mechanisms would make tackling NPS more effectively and efficiently in general. It would also improve the detection of substances, assign the most appropriate mechanism which should deal with a specific substance, and avoid duplication of work between the systems. ++ Final Report 106

113 Policy option 2.2 Improved coordination and referral to other EU legislation / mechanism mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Some positive impact, as better coordination and referral to other EU mechanisms would indirectly contribute to better prevention and reduction of health risks. As above. + Some positive impact, as this option might contribute to improved identification of NPS and related market developments. No impact. 0 High positive impact. Improved coordination and referral of new psychoactive substances to relevant EU legislation (e.g. EMA pharmaco-vigilance system, RASFF by EFSA etc.) would reduce grey zones between the instruments and not allow substances to go undetected by any of the mechanisms Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) At EU level, some investment would be required to organise the coordination, for example following notification of a substance or when discussing the need for a Joint Report. This would mainly require adapting procedures and protocols. Some inputs would be required from staff involved in the other EU mechanisms, to review the detected substance, or to forward a substance which they identified for review by the Council Decision mechanism. - Economic effects indirect cost increases Economic effects indirect costs reductions / benefits No set-up, running or administrative cost at national level. No impact identified 0 No impact identified 0 Final Report 107

114 Policy option 2.2 Improved coordination and referral to other EU legislation / mechanism Total 1- Social impacts Positive effects Low positive impact, as the policy option will ensure a higher coverage of + potentially harmful NPS, through better involvement of the various EU mechanisms. Negative effects No impact identified 0 Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Some positive impact: improved coordination and referral between EU instruments would in general strengthen consumer protection (Art 38) in a number of fields (e.g. drugs/ medicines/ food/ chemicals etc. legislation). 1 None identified 0 Other considerations Practicability / feasibility Acceptability The feasibility of improved coordination and referral between the relevant EU instruments is good, although clear procedures and guidelines will be needed. This is currently exemplified by the formal working relationship between EMA and EMCDDA in which the latter informs the former of any misuse of NPS (EWS is complementary with pharmaco-vigilance). There is added value in expanding such formal arrangements to other relevant instruments (e.g. RASFF by EFSA). The acceptability of the option is likely to be good as improved coordination and referral between relevant EU instruments logically generates positive outcomes for EU decision-making in general. In addition, several EU stakeholders have already expressed the view that interaction between the different EU instruments, or scientific committees should be reinforced. Total Cluster 3: Improving Early Warning System and Joint Report procedures As indicated in section 5, the following policy options were included within the Cluster 3: Policy Option 3.1 Improved conditions for Early Warning System (EWS) Policy Option Joint Report to include early toxic screen Policy Option Improved conditions for Joint Reports: Decision powers regarding Joint Reports The assessments of these policy options are presented in Table 6.6 to Table 6.8 below. Table 6.6 Improved conditions for Early Warning System (EWS) (PO 3.1) Policy option 3.1 Improved conditions for Early Warning System (EWS) Member States would be required, where possible, to share more information as soon as they notify (or re-notify) a substance through the EWS, including information on their chemical structure, toxicology, prevalence of use, health effects, etc. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle Medium positive impact: sharing information early on the chemical structure and prevalence, as well as health effects when known, would improve the capacity to respond to harmful NPS in a timelier manner, which is also evidence based. Final Report

115 Policy option 3.1 Improved conditions for Early Warning System (EWS) and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Some positive impact: early information sharing would indirectly feed into the prevention of potential harmful effects through their early identification, which would support quicker and evidence based action to prevent harms to health. Some positive impact, as above, the early sharing of evidence would speed up decision making, for example with regard to temporary measures, which could indirectly reduce social and economic costs of harmful NPS. The impact would be negligible: this option supports procedures that enable more evidence-based decision making on measures to tackle NPS and regulate market developments. Negligible impact: This option does not address the unintended effects from disjointed approaches by MS Negligible impact: This option does not address the regularly grey zones between EU instruments Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) At EU level, some costs would be incurred to develop additional guidelines on the format in which the information would best be submitted, possibly also requiring some changes to the EWS. At Member State level, no extra costs would be incurred as Member States would only be required to send the additional evidence if available. However, there may be benefit in also encouraging them to undertake some early testing or research, which would thus result in an additional cost. Member States would also need to invest some extra time for inputting the additional information into the EWS. Too low to substantiate - this option could contribute indirectly to increased law enforcement and justice costs, if market restriction or control measures were Economic effects 0 indirect cost increases taken. Economic effects Too low to substantiate - this option could contribute indirectly to reduction in 0 indirect costs healthcare costs through early identification enabling more timely response reductions / benefits Total 1- - Final Report 109

116 Policy option 3.1 Improved conditions for Early Warning System (EWS) Social impacts Positive effects No direct impacts. Indirect effects through early identification enabling more 0 timely response and hence reducing negative social effects Negative effects None identified 0 Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts No impact identified 0 None identified 0 Other considerations Practicability / feasibility Acceptability The policy option is feasible, but there is a chance that many Member States, without some explicit encouragement, will not undertake additional research and there will hence be no visible improvement to the current EWS. As above, many Member States may consider the policy option acceptable but they may not be willing to invest additional resources into providing the additional evidence. Total 0 Table 6.7 Joint Report to include early toxic screen (PO 3.2) Policy option 3.2 Joint Report to include early toxic screen The Joint Report would already include a first screening of the substance on toxicology. This would also allow for the launching of the urgency procedure (see also Cluster 6 below). 0 0 Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the Key anticipated impacts Medium positive impact: early screening of toxicology will both improve the early identification, and provide for a faster response to potentially harmful NPS. The positive impact would be strengthened if the policy option would be combined with temporary measures (see options 6.2 and 6.3). Some positive impact. Screening of toxicity at an early stage facilitates quick response capacity that will, indirectly and provided quick measures are taken, have an influence on preventing/reducing potential risks to health. Some positive impact, as above. + Some positive impact: early screening of toxicology, and particularly the launching of urgency procedure as a consequence, would help regulate the market dynamics. Rating Final Report 110

117 Policy option 3.2 Joint Report to include early toxic screen market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits No impact. 0 Some positive impact: early toxicology screen would help with better understanding of the toxicity of the substance and for which instruments it may be relevant to. Low to medium costs to the EU budget, to develop procedures for toxic screens and for undertaking the screening itself as part of the Joint Report. If undertaken by national laboratories, Member States will also incur some costs. The screening could also be undertaken through the networked /central ones as described under policy options 4.6 and 4.7). No impact 0 The option concerns a measure which will facilitate taking appropriate and timely action and could thus indirectly contribute to a reduction in healthcare costs. Total 1- Social impacts Positive effects There may be indirect effects through early identification, which would enable a 0 more timely response and hence a reduction of negative social effects. Negative effects None identified 0 Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts No impact identified None identified 0 Other considerations Practicability / feasibility The policy option is feasible, especially if the toxic screen was undertaken as part of the policy options related to the network of laboratories or central laboratory. If ++ Final Report 111

118 Policy option 3.2 Joint Report to include early toxic screen individual national laboratories were to be involved, these would need to work according to common standards. Acceptability The political acceptability would be good if the EU would carry the costs, possibly 0 Member States will be less in favour if national laboratories would have to undertake the toxic screening. Total 2+ Table 6.8 Improved conditions for Joint Reports: Decision powers regarding Joint Reports (PO 3.3) Policy option 3.3 Improved conditions for Joint Reports: Decision powers regarding Joint Reports The Commission, in addition to the Council, EMCDDA and Europol could also request a Joint Report. Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between Key anticipated impacts Some positive impact, as it could lead to greater efficiency if less time was spent on reaching agreement as to whether a Joint Report should be undertaken. Negligible positive impact. The faster finalisation of a Joint Report would improve the timeliness of measures taken to counter the negative effects of harmful NPS. As above. 0 No impact identified 0 No impact identified 0 No impact identified 0 Rating Final Report

119 Policy option 3.3 Improved conditions for Joint Reports: Decision powers regarding Joint Reports EU instruments and increase synergies Total rating score Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits Negligible running and administrative costs to the EU budget. No additional costs to MS budgets. No impact identified 0 No impact identified 0 Total 0 Social impacts Positive effects No impact identified 0 Negative effects No impact identified 0 Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Negligible positive impact, as the decision power of the Commission would only indirectly contribute to consumer protection by speeding up the overall procedure on NPS None identified 0 Other considerations Practicability / Not controversial +++ feasibility Acceptability Not controversial +++ Total Cluster 4: Research and analytical capacities on new psychoactive substances As indicated in section 5, the following policy options were included within Cluster 4: Policy Option Development of common criteria and guidelines for proactive monitoring Policy Option Introduction of a proactive monitoring system Policy Option 4.3 Introduction of a post risk assessment monitoring system Policy Option Introduce additional standardised tools and databases for risk assessments Policy Option Networking research facilities and forensic laboratories Policy Option Establishment of an EU research laboratory for new psychoactive substances The assessments of these policy options are presented in Table 6.9 to Table 6.14 below. Final Report 113

120 Table 6.9 Development of common criteria & guidelines for proactive monitoring (PO 4.1) Policy option 4.1 Development of common criteria and guidelines for proactive monitoring Specific criteria and methodological guidelines would be developed for the proactive monitoring of new psychoactive substances (possibly followed by the introduction of a proactive monitoring system under the intermediate approach). These would help the Reitox network members and Europol National Units to undertake any proactive monitoring according to common procedures and criteria, which substances to select for further examination (e.g. thresholds), etc. The current monitoring system used by EMCDDA could be further elaborated for this purpose. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Low positive impact, as the option concerns a 'preparatory measure'. A harmonised approach for the proactive monitoring of new substances would however have clear benefits over each Member State stakeholder working with different criteria. Low positive impact. Common criteria and guidelines will help the timely identification of potentially harmful substances and thus allow for appropriate action to be taken. Negligible impact. Indirectly the option might help to reduce economic, health and social costs. Negligible impact, some minor positive impact as common criteria and guidelines would improve the mapping of market developments. Negligible impact 0 Some positive impact. The guidelines could already refer to the need to check whether other EU instruments could be used to address substances when these are identified and hence increase awareness Final Report 114

121 Policy option 4.1 Development of common criteria and guidelines for proactive monitoring Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Low set-up cost to EU budget to develop common criteria and guidelines and disseminate these. Some training could also be envisaged, which would require the development of training materials and the delivery of training. Member States would need to incur minor administrative costs in order to familiarise themselves with the guidelines and have staff participate in training. - Economic effects indirect cost increases Economic effects indirect costs reductions / benefits No benefits identified No impact identified 0 No impact identified 0 Total 1- Social impacts Positive effects No impact identified 0 Negative effects No impact identified 0 Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts No impact identified. 0 No impact identified 0 Other considerations Practicability / The guidelines would form an important part of the implementation of the +++ feasibility proactive monitoring system under option 4.3. Acceptability Not controversial +++ Total 6+ Table 6.10 Introduction of a proactive monitoring system (PO 4.2) Policy option 4.2 Introduction of a proactive monitoring system This option would set up a proactive monitoring system to anticipate emerging threats, which would include the identification, test-purchasing, synthesising and studying of new compounds. Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS Key anticipated impacts High positive impact. Specific resources will be allocated to identifying new psychoactive substances which are introduced on the market. Priority should be given to analysing substances which appear highly popular and/ or potentially harmful, possibly supported by common criteria and thresholds (see option 4.2 above). User forums could be used to identify popular substances and/ or those considered harmful and test purchases will help to examine them. Support from industry may also be sought as part of this option. This objective would also improve the quantity and quality of information and research shared by EU and national authorities, and the efficiency of the mechanism. Rating +++ Final Report 115

122 Policy option 4.2 Introduction of a proactive monitoring system To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total score rating Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Medium positive impact. Proactive monitoring will help to identify harmful new substances at an earlier stage and to take appropriate action, which would thus indirectly help to prevent and/or reduce health risks. Medium positive impact. The early identification of potentially harmful new substances will help to reduce economic, health and social costs. Medium positive impact, as through the introduction of the system it would be possible to better 'map' market developments and to take action at an early stage to regulate some undesired dynamics. Neutral impact. On the one hand, the option could help to 'harmonise' Member State approaches whilst on the other, Member States could, based on the proactive monitoring activities, take decisions on new substances before any EU action. Some positive impact. The early identification of substances would also allow for an early assessment as to whether other EU instruments could best be used to address them. Medium set-up costs to the EU budget. The monitoring itself is likely to be undertaken at national level, whilst at EU level a central information system could be developed to collect the information and make it available to relevant stakeholders across the EU (software, hardware, IT inputs). In addition, some investment could be required to develop collaboration procedures with forensic and research institutes to collect and share information on reference materials (mainly human resources to develop protocols, etc.). In addition, some running costs could be incurred for processing and storing information on the central information system, and for the dissemination and cooperation with forensic and research institutes. Some administrative costs for familiarising relevant staff with the monitoring system could also be envisaged Economic effects indirect cost increases Member States would need to set up monitoring procedures based on a common approach and allocate human resources to the monitoring activities and, if considered necessary, testing of substances. Administrative costs would also need to be incurred for test purchases, and reporting findings to EU level central information system. Some running costs are also envisaged for familiarising relevant staff with the monitoring system. If appropriate action is undertaken, there will be some increased costs for law enforcement/ justice and some negative consequences for 'legitimate' industry, who would no longer be allowed to trade the substance. Also, if proactive monitoring leads to an overall increase in control (i.e. - Final Report 116

123 Policy option 4.2 Introduction of a proactive monitoring system Economic effects indirect costs reductions / benefits substances being banned without proper risk assessment), then there could be some displacement effects with indirect negative economic consequences. As the causal link is weak, these cannot be quantified. The economic impacts depend on the type of action undertaken as a result of the proactive monitoring activities. If harmful substances are indeed identified at an earlier stage and banned, there would potentially be an indirect reduction in healthcare costs. As the causal link is weak, these cannot be quantified. Total 2- Social impacts Positive effects If appropriate action is undertaken, there would be indirect positive social effects, + such as a reduction in physical and psychological harm, socially unacceptable behaviour, etc. Negative effects The social impacts depend on the type of action undertaken as a result of the - proactive monitoring. Indirect negative effects may arise if the option would lead to an overall increase in control measures, including increased criminalisation of young people in particular and legal uncertainty. Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Practicability / feasibility Acceptability If there would be an overall increase in control measures, thus leading to a high number of substances being banned, the freedom to conduct a business (Art 16) may be affected by limiting the right of businesses to conduct economic activities or to freely practice trade. Consumer protection (Art 38) could be improved if appropriate action is undertaken, as citizens would be better protected against potentially harmful substances. As already specified earlier, several unintended effects may occur if the option would lead to an overall increase in control measures, not supported by proper risk assessments, such as increased criminalisation of particularly young people, increases in the use of more harmful substances and a decrease in the quality of substances. Some impact on national systems as monitoring activities would mainly need to be undertaken at the national level. It may be difficult to ensure that all relevant stakeholders participate in 'feeding' the monitoring system with relevant information, possibly not all Member States would have the necessary capacity. Not controversial, although in the current economic crisis not all Member States may have the capacity to finance proactive monitoring activities. Total Table 6.11 Introduction of a post-risk assessment monitoring system (PO 4.3) Policy option 4.3 Introduction of a post-risk assessment monitoring system This option would introduce a monitoring and follow-up system specifically for substances which were the subject of a risk assessment report, but for which no control measures were taken. The monitoring would focus on the potential need to add new evidence related to recent developments and additional knowledge to the risk assessment, to allow for a re-assessment of the need to introduce control measures. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively High positive impact. A post-risk assessment monitoring system would improve the scientific capacity of the current mechanism and make the whole risk assessment process under it more robust, by ensuring that substances which have not been submitted to control measures are being continuously monitored for such need arising in the future. +++ Final Report 117

124 Policy option 4.3 Introduction of a post-risk assessment monitoring system anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches new psychoactive substances between Member States to To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Medium positive impact, as a post-risk assessment monitoring system would potentially be able to prevent health risks associated with NPS which are found to be more harmful over time than during the initial stage of risk assessment. Medium positive impact: if the option is able to prevent health risks associated with harmful NPS, as suggested above, it would contribute to reducing economic, health and social costs. Low positive/ negligible impact: the option would monitor the market of NPS which have not been subjected to control, thereby indirectly contributing to market regulation. No impact identified, as the policy option does not address this objective. 0 No impact identified, as the policy option does not address this objective Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Low one-off set-up cost to the EU budget, as the post-risk assessment monitoring system could be based on the existing risk assessment procedure. Medium running costs would be incurred as post-risk assessment monitoring might potentially be undertaken on a lot more substances than those subjected to control, as well as run in parallel to the monitoring of the latter. Low administrative costs might be involved in the training of staff on the post-risk assessment monitoring process of NPS. -- Economic effects indirect cost increases Low to medium set-up and running costs might be envisaged in the Member States for the same reasons as elaborated above. No impact identified 0 Economic effects No impact identified 0 Final Report 118

125 Policy option 4.3 Introduction of a post-risk assessment monitoring system indirect costs reductions / benefits Total 2- Social impacts Positive effects Low positive impact: as mentioned above, a post-risk assessment monitoring + system would in general contribute to prevention of social risks associated with the use of harmful NPS. Negative effects No impact identified 0 Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Practicability / feasibility Acceptability As the option would contribute to prevention of health and other social risks, it would indirectly contribute to strengthening consumer protection (Art 38), along with other measures. Medium positive impact, as the policy option might contribute to avoiding unintended negative consequences associated with the presence and use of NPS which are found to be more dangerous during post-risk assessment monitoring over time. The feasibility of the option is quite good, given that it could be based on the current risk assessment procedure established under the current mechanism. There might be some concern over the amount of cost necessary to maintain the post-risk assessment monitoring system, especially if such monitoring would be undertaken on an extremely large number of substances over a long period of time which would require substantial investment in this exercise. As above, the acceptability of the option is likely to be quite as Member States are generally in favour of active risk assessment policies. Nevertheless, there might be a certain level of financial concern both in the EU and especially in Member States, particularly in the current crisis context. Total Table 6.12 Introduce additional standardised tools and databases for risk assessments (PO 4.4) Policy option 4.4 Introduce additional standardised tools and databases for risk assessments This proposal would introduce additional common methods, tools and instruments for risk assessments, especially concerning new psychoactive substances for which very little scientific evidence on their effects is available. With respect to prevalence studies, this would, for example, include the development of standard sets of survey questions (which require a minimum of adaptation to tailor it to a different substance) for surveys to users and organisations working with potential users. The option could also include the development of a common, EU wide database of drug users and relevant organisations in the field, who are in principle willing to respond to surveys (e.g. similar to the European Business Test Panel), so that risk assessments can involve a large group of respondents within a relatively limited time period. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to Medium positive impact. Additional standardised tools for risk assessments would help to further increase the capacity and efficiency of the EU mechanism, and in particular improve the evidence base and quality of the risk assessment. Final Report

126 Policy option 4.4 Introduce additional standardised tools and databases for risk assessments efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ Some positive impact. Indirectly, the additional tools would allow for more + or reduce the appropriate market restriction and control measures following risk assessments, potential risks to which should help to prevent and reduce possible health risks. health of harmful new psychoactive substances To reduce the Negligible positive impact. Indirectly, the additional tools would allow for more 0 economic, health and social costs appropriate market restriction and control measures following risk assessments, which should help to reduce economic, health and social costs of harmful new generated by psychoactive substances. harmful new psychoactive substances To better account for, and where necessary, Some positive impact. Indirectly, an EU survey tool could ask users to also ask respondents to indicate about other new substances they have recently used, which may help to better 'map' the market. + regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by Negligible positive impact: This option does not address the unintended effects from disjointed approaches by Member States, but improved risk assessments may contribute to Member States being more prone to taking a common approach based on a recommendation or decision by the EU. 0 differences in approaches to new psychoactive substances between Member States To eliminate No impact identified 0 regulatory grey zones between EU instruments and increase synergies 4+ Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Medium set-up costs to EU budget, depending on the type of standardised research tools and databases for storing information which might be introduced. The development of an EU-wide database of potential users, for example, would require a substantial one-off investment, as well as running costs for continuous management of the list of respondents, the development of surveys, etc. Some (minimum) investment may be required by Member States to ensure set up and use of the common methods and tools, including the survey at national level, dissemination of information, supporting the identification of users, etc. MS would only incur some minor running costs, with regard to the update of tools which may require some national investment. -- Economic effects indirect cost No benefits identified None identified 0 Final Report 120

127 Policy option 4.4 Introduce additional standardised tools and databases for risk assessments increases Economic effects indirect costs reductions / benefits Improved risk assessments will allow the EU to take more appropriate market restriction and control measures, which would help to reduce healthcare costs and possibly productivity losses. Total 1- Social impacts Positive effects Positive indirect effects would include reduced physical and psychological harm. + This would however strongly depend on the type of market restriction and control measures taken. Negative effects None identified 0 Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Potential adverse impacts on data protection in case of surveys (Art 8 Protection of personal data) regarding the database of potential users. These should be provided with the opportunity to be fully anonymous. The collection of such data has to fulfil the requirements set out in Article 8 (including data subject's consent or other legitimate basis laid down by law). Some positive impact on consumer protection (Art 38), as more robust risk assessments would lead to better informed decision making on market restriction and control measures. Indirectly, unintended effects in general could be reduced if the market restriction and control measures would be more appropriate. Practicability / The practicability of the option might be low considering that some of the new - feasibility tools could be very costly. Acceptability The political acceptability of the option is good, as Member States are overall ++ strongly in favour of improved risk assessments. Total Table 6.13 Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA (PO 4.5) Policy option 4.5 Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA Under this option, the EU's research and analytical capacity on new psychoactive substances would be improved. Its capacity to produce rapidly forensic, toxicological and pharmacological data on new psychoactive substances, to support and strengthen the collection of information on the potential harms of a substance and assess its risks would be enhanced. This would be done by supporting structural collaboration European research institutions (including the Joint Research Centre JRC), in coordination with the EMCDDA, and promote cooperation between the EMCDDA and forensic laboratories' networks, such as the European Network of Forensic Science Institutes. This would facilitate the development and sharing of forensic information and research findings on new psychoactive substances. This network would also support the development of systems to collect epidemiological data (including the standardisation of survey methodologies, protocols and data collection methods), help disseminate information (including on prevention) and reassess the harms of substances. It would help to develop common EU criteria and guidelines for the proactive monitoring of the market (internet monitoring, test-purchasing), which national authorities will be invited to implement voluntarily. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the High positive impact. The overall scientific (forensic and research) capacity and efficiency of the mechanism would be greatly improved through supporting structural cooperation between existing EU research institutions and promoting further cooperation between the EMCDDA and ENFSI. Such collaboration could Final Report

128 Policy option 4.5 Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA current mechanism to also be highly useful for the implementation of many of the other options, such as work on the EU reference list on harms associated with licit and illicit efficiently and psychoactive substances, proactive monitoring and the use of improved risk effectively assessment tools. This option would also improve the quantity and quality of anticipate, tackle information and research shared by EU and national authorities. and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States Medium positive impact. The network would contribute to increased knowledge on psychoactive substances which would help to make better informed decisions concerning urgency, market restriction and control measures. These would in return contribute to improved prevention and reduction of health risks. Medium positive impact. The network would contribute to increased knowledge on psychoactive substances which would help to make better informed decisions concerning urgency, market restriction and control measures. These would in return contribute to reduce economic, health and social costs. Medium positive impact. The network would increase the overall capacity to map and examine new psychoactive substances, which will also help to better understand the market dynamics. However, the extent to which these can be successfully regulated will depend on the types of measures taken. Some positive impact as the network will contribute to improved decision making on market restriction and control measures, which may help to reduce perverse effects. To eliminate Some positive impact as the network would enable the faster identification of + regulatory grey substances which may fall under other EU instruments. zones between EU instruments and increase synergies 11+ Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Relatively high costs to EU budget to finance the set up and running of the networked laboratories (through a grant or framework contract), including the development of systems to collect epidemiological data, standardisation of survey methodologies, protocols and data collection methods. In addition, some running costs are envisaged for coordinating the network, and for cooperation between EMCDDA, ENFSI and the network, including exchange of forensic and toxicology information. Medium costs are anticipated to MS budgets. Forensic and research institutes may have to invest in adapting their working processes to become part of the network (in addition to the EU funding they will Final Report 122

129 Policy option 4.5 Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA receive) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits None identified 0 The networked laboratories and institutes would allow the EU to take more timely and appropriate market restriction and control measures, which would indirectly lead to cost reductions in healthcare and, possibly, productivity losses. As the causal link is weak, these cannot be quantified. Total 0 Social impacts Positive effects Indirect positive effects would include reduced physical and psychological harm, ++ as the option would generate better evidence enabling more timely and appropriate responses. Negative effects None identified 0 Total 2+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Timely and accurate response is likely to reduce harm to health, hence enhance the rights as regards consumer protection (Art 38) None identified 0 Other considerations Practicability / feasibility Acceptability The selection process of the forensic laboratories and research facilities would be very important, to ensure that as a network they can address the full spectrum of new psychoactive substances and have the capacity to undertake all forensic testing and research required. It will also be important to ensure that the EU has sufficient funding to finance the network on the medium to long term. Finally, the network should be accompanied by some kind of central storage function, to make sure that all knowledge collected and gained can be accessed by all relevant stakeholders. Political acceptability is likely to be good, as there is a clear added value of networking laboratories and institutes, rather than individual approaches. It is also preferable over a central function as it would make use of existing expertise which would also continue to undertake national activities. The function is central to improving the knowledge and capacity of the EU system as regards risk management, but also possibly in relation to proactive monitoring and wider ongoing research. Total Table 6.14 Establishment of an EU research laboratory for new psychoactive substances (PO 4.6) Policy option 4.6 Establishment of an EU research laboratory for new psychoactive substances This option entails the permanent expansion of EU research capacity in this field by establishing laboratory functions in one identified research facility (JRC) or EU Agency (EMCDDA). This laboratory may have the same functions as mentioned under the previous policy option, allowing the assessment and ongoing monitoring of the availability of specific substances at the EU level. Key assessment criteria Policy objectives Key anticipated impacts Rating Final Report 123

130 Policy option 4.6 Establishment of an EU research laboratory for new psychoactive substances To improve and Medium positive impact. The designated laboratory or EU agency would ++ increase the contribute to the proactive monitoring of the NPS market at both EU and national (scientific) level, improve the quantity and quality of information and research shared by EU capacity of the current and national authorities, and improve the overall efficiency of the EU mechanism to identify, monitor and assess these substances. It would also ensure that the mechanism to risks caused by NPS are identified though a scientifically robust assessment. efficiently and However, being at central level the laboratory would not be directly involved in effectively the detection of NPS and would thus heavily depend on the extent to which it anticipate, tackle and respond to harmful NPS receives useful inputs from the Member States and the Council Decision mechanism. Particularly the Member States may prefer to continue using their own laboratories. To prevent and/ Medium positive impact. The designated laboratory or EU agency would ++ or reduce the contribute to increased knowledge on NPS which would help to make better potential risks to health of harmful new informed decisions concerning control measures or temporary or permanent market restrictions. These would in return contribute to improved prevention and reduction of health risks. psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances Medium positive impact. The designated laboratory or EU agency would contribute to increased knowledge on NPS which would help to make better informed decisions concerning control measures or temporary or permanent market restrictions. These would in return contribute to improved prevention and reduction of health risks. These would in return contribute to reduce economic, health and social costs. ++ To better Medium positive impact. The designated laboratory or EU agency would ++ account for, and where necessary, increase the overall capacity to map and examine NPS, which would also help to better understand the market dynamics. This in turn would contribute to improved decision making on control measures or market restrictions. Possibly regulate the its central position will favour its capacity to generate a full overview of the EU market market. dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended Some positive impact as the EU laboratory or agency will contribute to improved and more evidence-based decision making on control measures or market restrictions, which may help to reduce unintended perverse effects. + effects caused by differences in approaches to new psychoactive substances between Member States To eliminate Some positive impact as the laboratory would enable the faster identification of + regulatory grey substances which may fall under other EU instruments. zones between EU instruments and increase synergies 10+ Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) High cost to EU budget to finance the set up and running of a central EU laboratory, including the purchasing of expensive machinery to undertake testing (e.g. NMR spectroscopy, high-resolution mass spectrometry, GC-MS, ion mobility spectrometry (IMS), thin layer chromatography (TLC), and TLC-MS, high performance liquid chromatography (HPLC), etc.). In addition, running costs are expected for ca. 50 staff who would be responsible for activities such as testing of substances, undertaking research on risk assessments, running of epidemiological and prevalence studies, coordination between MS etc Final Report 124

131 Policy option 4.6 Establishment of an EU research laboratory for new psychoactive substances Economic effects indirect cost increases Economic effects indirect costs reductions / benefits Minor cost to MS budgets. Some cost to the budgets of research facilities for providing samples or other relevant data to the laboratory including transportation or mailing costs, as well as administrative burden in completing sample transmission sheets. None identified 0 The designated laboratory or EU agency would allow the EU to take more timely and appropriate control measures or market restrictions, which would indirectly lead to cost reductions in healthcare and other social costs. As the causal link is weak, these cannot be quantified. Total 1- Social impacts Positive effects Indirect positive effects would include reduced physical and psychological harm, ++ as the option would generate better evidence enabling more timely and appropriate responses in terms of control or market restriction measures. Negative effects None identified 0 Total 2+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Timely and accurate response is likely to reduce harm to health and therefore offer improved consumer protection (Art 38) None identified 0 Other considerations Practicability / feasibility Acceptability Feasibility is likely to be very low given the high set up, maintenance and human resource costs associated with establishing and maintaining laboratory functions in an EU agency, particularly in the current economic climate. It might be difficult for such a central facility to collect seized/ otherwise materials as some Member States will prefer using their own laboratories. There may also be some duplication of efforts. Finally, it is questionable whether a central laboratory would have sufficient work to justify its existence. Political acceptability is likely to vary between Member States but would generally be low, given the current economic climate and the amount of cost associated with the implementation of the policy option. However, a central EU laboratory/ agency identifying NPS might be helpful for smaller Member States in synthesising reference materials and providing relevant analytical data to them. Total Cluster 5: Addressing new psychoactive substances individually or in a group As indicated in section 5, the following policy options were included within the Cluster 5: Policy Option Generic approach by group of substances Policy Option Analogue approach by group of substances The assessments of these policy options are presented in table 6.15 and Table 6.16 below. Table 6.15 Generic approach by group of substances (PO 5.1) Policy option 5.1 Generic approach by group of substances This option would allow for assessing the risks and making decisions on several new psychoactive substances at the same time, based on their similar chemical structure. The risk assessment could start with an individual Final Report 125

132 Policy option 5.1 Generic approach by group of substances substance, and when appropriate also considering their generic context, providing, where possible, for an intelligent grouping of substances (i.e. reviewing the possible emergence of chemically related substances and their anticipated risks). But since substances that are chemically similar can have very different effects and pose different risks, the generic risk assessment would in practice mean assessing the risks of one substance and extrapolating results to a group of related substances (without assessing their particular risks). Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase Key anticipated impacts Medium positive impact, as the risk assessment would anticipate the emergence of substances which are highly similar in chemical structure, which could be released on the market as soon as the substance which is assessed would be subjected to market restriction or control measures. Medium positive impact, as this approach to risk assessments would help to take more appropriate market restriction and control measures, which in turn would lead to a reduction of health risks of certain (groups of) substances and strengthen prevention. Some positive impact. Indirectly, the generic approach would allow for more appropriate market restriction and control measures following risk assessments, which should help to reduce economic, health and social costs of harmful new psychoactive substances. Medium positive impact. The revised approach to risk assessments would in fact anticipate market dynamics by identifying chemically related substances which may be introduced as soon as a substance is subjected to market restriction or control measures. Unintended effects could emerge if an entire group of substances would be banned as a whole, including prohibition of substances which do not have psychoactive effects and unnecessary criminalisation of users, increase in the emergence and use of more harmful substances, decrease in the quality of substances, and an increase in the size of the black market. No impact identified 0 Rating Final Report 126

133 Policy option 5.1 Generic approach by group of substances synergies Total 5+ Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Some (relatively low) set-up costs for adapting risk assessment procedures to generic approach, including the revision of the current guidelines and possibly some training. Some running costs as this kind of risk assessment process would mean that more than one substance would need to be considered at a time. Per risk assessment, it would imply a cost increase, as multiple NPS would be considered. However, there will be slightly fewer risk assessments as substances would be considered as a group this outweighs the cost increase per risk assessment, hence the option is cost-neutral. - No cost to MS budgets. Economic effects Initially, some increased law enforcement and judicial costs because of the fact - indirect cost that control measures may be applied to multiple substances. increases Similarly, industry might also suffer more from multiple substances being banned or otherwise restricted. Economic effects The expanded risk assessment would allow the EU to take more appropriate + indirect costs market restriction and control measures, which would indirectly lead to cost reductions / reductions in healthcare and, possibly, productivity losses. As the causal link is benefits weak, these cannot be quantified. Total 1 - Social impacts Positive effects Positive effects would include reduced physical and psychological harm, ++ especially because the option would anticipate the emergence of additional substances and put appropriate measures in place beforehand, thus contributing to prevention of potential harm of substances. Negative effects As mentioned above, if an entire group of substances is banned, this could - include substances which do not have psychoactive effects, which in turn might lead to some unnecessary control and criminalisation of users. Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts The option would potentially have some positive impact on consumer protection (Art 38), as users would be made aware of the potential harmful effects of a group of NPS. The policy option would also prevent the appearance of more harmful, highly similar substances. Indirectly, if groups of substances would be banned, there might be some unintended effects such as prohibition of substances which have no psychoactive effects, criminalisation of people, increase of the black market or decrease of the quality of substances Practicability / feasibility Acceptability Ultimately, the risk assessment would need to examine the details of a single substance in detail (whilst 'anticipating' the effects of substances with a highly similar chemical structure), which may make any restriction or control measures difficult to justify without an individual risk assessment. Also, only part of the Member States has a generic approach to market restriction and control measures for NPS. Any EU recommendation or decision which would emerge on this basis could thus be challenging to implement. The political acceptability of the option is good, as Member States support the need to address specific groups of substances and as some have generic approaches in place Final Report 127

134 Policy option 5.1 Generic approach by group of substances Total 1+ Table 6.16 Analogue approach by group of substances (PO 5.2) Policy option 5.2 Analogue approach by group of substances This option would allow for assessing the risks and making decisions on several new psychoactive substances at the same time, based on their similar pharmacological effect. This could in particular apply to groups of substances which mimic the same drug (e.g. the synthetic cannabinoids imitating cannabis) that separately may not warrant a risk assessment to be undertaken but as a group cause an EU-wide concern. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Medium positive effect as some of the aggregate harms and risks of certain groups of substances, such as synthetic cannabinoids, could be discussed in a single risk assessment. This would allow the EU mechanism to propose more appropriate market restriction and control measures than when assessing only the individual substance. Medium positive impact, as this approach to risk assessments would help to take more appropriate market restriction or control measures, which in turn would lead to a reduction of health risks of certain (groups of) substances and strengthen overall prevention. Some positive impact. Indirectly, the approach would allow for more appropriate market restriction and control measures following risk assessments, which should help to reduce economic, health and social costs of harmful new psychoactive substances. Neutral impact. The option may influence market dynamics in the sense that it would identify and deal with a group of substances, applying the same market restriction and control measures to all those included. This would help to avoid that variations on the substance would emerge/ continue to be on the market and cause harm. On the other hand, the approach is likely to cause substantial market uncertainty, as legitimate market operators will encounter difficulties in understanding which substances are part of potential market restriction or control measures and which can still be produced, distributed and sold. Unintended effects could emerge if an entire group of substances would be banned as a whole, including prohibition of substances which do not have psychoactive effects and unnecessarily criminalising users, increase in the use of more harmful substances, decrease in the quality of substances, and an increase in the size of the black market. As mentioned above, some companies may trade substances without realising that they could be sanctioned or even prosecuted. No impact identified Final Report 128

135 Total score rating 2+ Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Low set-up costs to EU budget for adapting risk assessment procedures to analogue approach, including the revision of the current guidelines and possibly some training. Risk assessment process may require additional running resources as more than one substance at a time would need to be considered. The risk assessment process would also require more human and financial resources to review groups of substances. As above cost-neutral. No cost to MS budgets. - No benefits identified Economic effects Initially, some increased law enforcement and judicial costs because of the fact - indirect cost that control measures could be applied to multiple substances, which in increases addition are not clearly defined. This would thus lead to additional costs for examining whether indeed a certain substance can be considered analogue. Similarly, industry might also suffer more from multiple substances being banned or otherwise restricted. There are also costs associated with the legal uncertainty as to whether substances are banned or not. Economic effects The expanded risk assessment would allow the EU to take more appropriate + indirect costs market restriction and control measures, which would indirectly lead to cost reductions / reductions in healthcare and, possibly, productivity losses. As the causal link is benefits weak, these cannot be quantified. Total 1- Social impacts Positive effects Positive effects would include reduced physical and psychological harm, ++ especially because the option would address substances which were known to be harmful, but which individually did not meet the 'threshold' for risk assessments. Negative effects If an entire group of substances is banned, this could include substances - which do not have psychoactive effects, which in turn might lead to some unnecessary control and criminalisation of users. Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts The option would potentially have some positive impact on consumer protection (Art 38), as users would be made aware of the potential harmful effects of a group of NPS. The policy option would also prevent the appearance of more harmful, highly similar substances. However, the principle of principles of legality and proportionality of criminal offences and penalties (Art 49) might be breached, considering that users and businesses risk to inadvertently engage in criminal, or otherwise prohibited, behaviour. The policy option would affect legal certainty, as it would be difficult to prove whether or not a substance could be considered analogue to another. Indirectly, if groups of substances would be banned, there might be some unintended effects such as a high level of legal uncertainty for both users and businesses, prohibition of substances which have no psychoactive effects, criminalisation of people, increase of the black market or decrease of the quality of substances Practicability / feasibility Acceptability The option is only feasible for very specific groups of substances such as synthetic cannabinoids which mimic the same drug (i.e. cannabis), which are highly diverse in terms of chemical structure, yet have the same pharmacological effects. It may therefore not be practical to put general provisions for risk assessments in place. Also, only a minor share of the Member States has an analogue approach to market restriction and control measures concerning NPS. Any EU recommendation or decision which would emerge on this basis could thus be challenging to implement. The political acceptability of the option is reasonable, as Member States generally support the need to address specific groups of substances and Final Report 129

136 enhance preventative measures. However, only few have analogue approaches in place. Total Cluster 6: Temporary emergency measures As indicated in section 5, the following policy options were included within the Cluster 6: Policy Option 6.1 Urgency Joint Report procedure for toxic substances Policy Option EU recommendation to introduce temporary emergency measures Policy Option EU decision to introduce temporary emergency measures Policy Option Extending of Risk Assessment period during temporary restriction The assessments of these policy options are presented in Table 6.17 to Table 6.20 below. Table 6.17 Urgency Joint Report procedure for toxic substances (PO 6.1) Policy option 6.1 Urgency Joint Report procedure for toxic substances As part of the Early Warning System, specific criteria would be developed to activate an urgency procedure for preparing a Joint Report for new substances which appear to have a high level of toxicity and / or on which initial reports on adverse health consequences raise particular concerns in several Member States. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk Medium positive impact, as the capacity of the current mechanism to directly deal with NPS which appear harmful would be improved, especially if combined with policy option 3.5 above (i.e. allowing the Commission, EMCDDA and Europol to request a Joint Report). Some positive impact, as the faster finalisation of a Joint Report would improve the timeliness of measures taken to counter the negative effects of harmful NPS. As above + No impact Final Report 130

137 Policy option 6.1 Urgency Joint Report procedure for toxic substances To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits No impact. 0 No impact. 0 At EU level, some negligible additional administrative costs for developing and implementing new procedures for launching a Joint Report. In terms of running costs, it is likely that the number of Joint Reports produced per year will increase. No direct impact. 0 No direct impact. 0 Total 0 Social impacts Positive effects No direct impact. 0 Negative effects No direct impact. 0 Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts No direct impact None identified 0 Other considerations Practicability / feasibility Acceptability The introduction of an emergency procedure for developing Joint Reports is practicable and feasible, as it would merely require the development of some additional guidelines and procedures. Member States would welcome the introduction of an emergency procedure which would help to confirm, within a short time period, whether a certain NPS would be particularly harmful and require urgent action. Total Final Report 131

138 Table 6.18 EU recommendation to introduce temporary emergency measures (PO 6.2) Policy option 6.2 EU recommendation to introduce temporary emergency measures On the basis of the results of the joint report produced by the EMCDDA and Europol, the Commission can recommend to the Member States to introduce emergency measures to restrict the production, trade and sale of a new psychoactive substance that poses immediate concerns. This measure only concerns the use of the substance for its psychoactive effect; it will not restrict its availability for research and legitimate industrial uses. If the risk assessment shows that the substance poses severe risks, the emergency measures will be made definitive by scheduling the substance on a restricted substances list. The purpose of the measure is to ensure that the substance can be assessed thoroughly without consumers being exposed to its potential harms until its actual risks are identified. The emergency measures should have a limited duration (maximum one year, renewable once) and should automatically expire after that time. Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances Key anticipated impacts Medium positive impact: although the scientific capacity would not be improved, this option would increase the effectiveness of the mechanism to respond to harmful NPS, by providing for a temporary stop on their production, distribution and sale. It would also improve the efficiency of the mechanism, as the recommendation could already be issued after a joint report has been produced. Medium positive impact. This option would indirectly help prevent potential risks to health through early market restriction. Such fast action would in particular be highly beneficial if, for example, a NPS which had become very popular would present some unexpected harmful effects in the short (but not direct) term or would be particularly harmful for certain user groups (e.g. persons taking certain medication). However, as the EU would only issue a recommendation, part of the Member States may not implement it. Low positive impact. The option may help to reduce longer-term economic, health and social costs, for the reasons set out above, but not all Member States may implement the measure. Also, there is a risk that the temporary measure may expire before an informed decision can be taken on future restrictions or control measures. To reduce the + economic, health and social costs generated by harmful new psychoactive substances To better account Medium positive impact: early market interventions would help regulate the ++ for, and where market dynamics, in particular by quickly responding to harmful NPS as soon as necessary, these are put on the market, in a way which is proportionate to the risk they regulate the market pose. dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or Some positive impact, as the recommendation would apply to all Member + reduce unintended States, even though there is a risk that part of the Member States will not effects caused by implement the recommended measure. Traders could thus, move the sales of differences in NPS for example to another country. approaches to new psychoactive substances between Member States To eliminate No impact identified. 0 regulatory grey zones between EU instruments and increase synergies Total rating score 8+ Rating Final Report 132

139 Policy option 6.2 EU recommendation to introduce temporary emergency measures Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) For the assessment of the economic effects, it is assumed that the EU would issue a recommendation on a temporary market restriction for two NPS per year and that the measure would last maximum two years. It is also assumed that 50% of the MS would implement such measure (as the recommendation is not binding). The EU would incur some set-up costs for the emergency procedure, as part of the Joint Report guidelines. Running costs would be minimal; possibly there is an increase in the number of Joint Reports produced annually. In terms of administrative costs, these would relate to the development of the new legislation and familiarisation with the legislative instrument and procedure. - - Economic effects indirect cost increases Member State costs would relate to monitoring compliance with the temporary market restriction in the Member States, issuing sanctions for non-compliance, etc. This would be similar to monitoring trade of NPS under permanent control. They would also incur some administrative costs for familiarising with the new procedure and for informing the EU on the functioning of the temporary restriction. There may be some loss in tax revenues from legitimate companies, over two years maximum although it is rather likely that a NPS, once subject to a temporary measure, will subsequently be restricted / banned permanently. Industry will need to incur costs for ensuring compliance with a temporary measure and for regular monitoring of decisions as part of the new procedure, which also allows quick freeze on production, trade and sale, and placing these substances on a 'ban list'. Costs for investigations and prosecutions / trial would increase as a result of the temporary measure. Companies would no longer be able to produce, distribute and sell NPS being subject to the ban for a period between 1-2 years, which would lead to a loss of revenue. If it was a highly popular NPS, some may have to stop their business (but unlikely). Some reduction in healthcare costs, as a harmful substance would be controlled, as well as related social costs (e.g. loss of productivity). Economic effects ++ indirect costs reductions / benefits Harm reduction is estimated at 5%. Total 1 - Social impacts Positive effects The availability of a harmful substance is temporarily restricted in the EU, which + would reduce health-related risks and other harms to persons and society. Negative effects If already a popular substance / product among users, the NPS may become - traded in the illicit market, which may also negatively affect its quality. Total 0 - Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Enhanced consumer protection (Article 38), as a harmful NPS would be removed from the market. Especially if not all Member States would implement the EU recommendation, there is a risk of producers, distributors and sellers moving to those countries which do not have the restrictions in place. A restriction could also mean a move of the NPS to the illicit market, with involvement of criminal groups. + 0 Final Report 133

140 Policy option 6.2 EU recommendation to introduce temporary emergency measures Practicability / feasibility There appear to be no, or little, practical problems in implementing the measure. However, there are questions over whether a substance under temporary restriction would ever be released from such restriction because it is assessed 'safe'. 0 Acceptability In addition, as this is a non-binding measure Member States may not implement it. This is a real risk and might also lead to (further) market distortion, as industry (producers, distributors and sellers) would work with different procedures in different MS. The public acceptability of the measure is good as this measure would reduce the availability of harmful substances/products in the market. In addition, the political acceptability is also likely to be relatively high, aside from implementation costs and some reservations on risk of other 'legitimate businesses' suffering as a consequence. The industry distributing these substances is likely to have reservations on this measure. Although in principle possibly agreeing on restricting harmful substances, what is considered as harmful is likely to vary. + + Total 2 + Table 6.19 EU decision to introduce emergency measures (PO 6.3) Policy option 6.3 EU decision to introduce temporary emergency measures Same as above, but the temporary emergency measures will be binding on Member States. To ensure rapidity of action, this decision will be taken through a delegated act. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk Same effects as the EU recommendation on temporary emergency measures, medium positive impact. Similar effects as the EU recommendation on temporary emergency measures, high positive impact. The effect of the EU decision would be stronger, as all Member States would be required to implement the temporary measure. Similar effects as the EU recommendation on temporary emergency measures, medium positive impact. The effect of the EU decision would be stronger, as all Member States would be required to implement the temporary measure. Same effects as the EU recommendation on temporary emergency measures, medium positive impact Final Report 134

141 Policy option 6.3 EU decision to introduce temporary emergency measures To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Similar effects as the EU recommendation on temporary emergency measures, medium positive impact. The effect of the EU decision would be stronger, as all Member States would be required to implement the temporary measure. No impact identified. 0 Total rating score Economic impacts Budgetary Same effects as the EU recommendation on temporary emergency measures, - - consequences to even though this time these would be occurred by all Member States and the EU, Member businesses. States and other stakeholders (e.g. industry) Economic effects Same effects as the EU recommendation on temporary emergency measures, -- indirect cost even though this time these would concern all Member States and all increases businesses. Economic effects Same effects as the EU recommendation on temporary emergency measures, ++ indirect costs even though this time these would concern all Member States. reductions / Harm reduction is estimated at 10%. benefits Total 2 - Social impacts Positive effects Same effects as the EU recommendation on temporary emergency measures. + Negative effects Same effects as the EU recommendation on temporary emergency measures. - Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Practicability / feasibility Acceptability Same effects as the EU recommendation on temporary emergency measures. + Lower risk of unintended impacts as the measure would apply to all Member States, hence producers, distributors and sellers could not move to other EU countries. There would be the risk of a move of the NPS to the illicit market, with involvement of criminal groups. There appear to be no, or little, practical problems in implementing the measure. However, there are questions over whether a substance under temporary restriction would ever be released from such restriction because it is assessed 'safe'. The public acceptability of the measure is good as this measure would reduce the availability of harmful substances/products in the market. In addition, the political acceptability is also likely to be relatively high, aside from implementation costs and some reservations on risk of other 'legitimate businesses' suffering as a consequence. The industry distributing these substances is likely to have reservations on this Final Report 135

142 Policy option 6.3 EU decision to introduce temporary emergency measures measure. Although in principle possibly agreeing on restricting harmful substances, that what is considered as harmful is likely to vary. Total 3 + Table 6.20 Extending Risk Assessment period during temporary restriction (PO 6.4) Policy option 6.4 Extending Risk Assessment period during temporary restriction The temporary restriction measure of a harmful new substance, would allow for more time for the Risk Assessment to explore in detail its harm. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States Medium positive impact: this option would improve and increase the scientific capacity of the current mechanism in undertaking risk assessment of substances over an extended period of time. Some positive impact. Once a temporary restriction measure has been taken, the extended risk assessment period would allow for an in-depth review of available evidence as to the potential risks of the NPS. Further appropriate measures could be taken as a result. As above. + Some positive impact, as the policy option would allow for better decisionmaking on NPS and hence improved market regulation. No impact Final Report 136

143 Policy option 6.4 Extending Risk Assessment period during temporary restriction To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Economic effects indirect cost increases Economic effects indirect costs reductions / benefits No impact. 0 At EU level, there would be some administrative and set-up costs to accommodate for the new procedure. The option would not affect the way in which risk assessments would be undertaken, hence there would be no additional implementation costs. It is however assumed that the number of risk assessments will increase. Negligible additional costs at national level. No impact identified 0 No impact identified 0 Total 0 Social impacts Positive effects No direct impact, positive impact is accrued by the temporary measure taken as 0 part of policy options 6.2 or 6.3 above. Negative effects As above. 0 Total 0 Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts No direct impact identified No direct impact identified 0 Other considerations Practicability / feasibility Acceptability Not controversial, especially as there have already been positive views expressed from stakeholders with regard to prolonging the duration of the risk assessment stage in order to increase its scientific credibility. Not controversial, though some concern might arise if the length of the overall procedure under the current EU mechanism rises significantly. Total Final Report 137

144 6.10 Cluster 7: Final decision on a new psychoactive substance As indicated in section 5, the following policy options were included within the Cluster 7: Policy Option EU decision to submit substance to criminal law control measures or to recommend permanent market restriction measures Policy Option EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures Policy Option EU prescribing the measure and outcome of control and risk management The assessments of these policy options are presented in Table 6.21 to Table 6.23 below. Table 6.21 EU recommendation to submit substance to criminal law control measures or to recommend permanent market restriction measures (PO 7.1) Policy option 7.1 EU recommendation to submit substance to criminal law control measures or to recommend permanent market restriction measures Under this scenario, once the risk assessment is concluded, the EU would have different alternatives for action. If the risk assessment proves that a new psychoactive substance poses severe risks to health and safety of individuals, the Commission can decide to add the substance to a list of substances submitted to criminal control measures across the EU (by means of a delegated act). However, if the risk assessment proves that a new psychoactive substance has a moderate or low risk to health and safety, the Commission can recommend to the Member States to introduce market measures permanently restricting the production, trade and sale of the new psychoactive substance, without restricting availability for research and legitimate industrial uses (by means of a delegated act). If the Commission decides that no further measures are necessary, it should justify why. Possible market restriction measures could include: - Permanent market restriction prohibiting import/ export - Permanent market restriction, prohibiting manufacture, production, trade, distribution and sale Possible control measures could include: - Permanent control, making import/ export, manufacture production, trade, distribution and sale a criminal offence - Permanent control making possession an offence. The above measures would not restrict the availability of new psychoactive substances for research and legitimate industrial uses. Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances Key anticipated impacts Medium positive impact. Following an in-depth risk assessment, the mechanism would have the possibility to respond proportionately, according to the harm posed by the NPS. The most harmful NPS could be made subject to criminal control measures whilst for those representing moderate harm, market restriction measures could be put in place. The mechanism would strongly benefit from other policy options, such as the improved risk assessment tools and the networking of laboratories. Medium positive impact. Appropriate permanent market restriction or control measures would limit the availability of harmful NPS and hence reduce their negative health effects. It will be important to ensure that the measure is proportionate to the risk posed by the NPS, as banning multiple substances may have important unintended effects, as discussed further below. Also, the EU could only recommend market restriction measures, which means that several Member States may not implement the measure. Rating Final Report 138

145 Policy option 7.1 EU recommendation to submit substance to criminal law control measures or to recommend permanent market restriction measures To reduce the Some positive impact. The option may help to reduce longer-term economic, + economic, health and social costs health and social costs, for the reasons set out above, but not all Member States may implement the measure. generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Some positive impact. Whilst contributing to better accounting for and regulating the NPS market, the measures would be reactive and it may take some time before they can be taken. The extent to which measures are proportionate will need to be carefully monitored so as not to trigger negative market dynamics (e.g. the fast appearance of other, possibly even more harmful, substances). As the recommendation is not binding, displacement effects could occur (traders moving production, distribution and sales to a Member State which did not implement the measure). No impact identified Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) No set-up and low running costs to the EU budget. Some administrative costs in terms of monitoring permanent restriction or control measures implemented across the EU. Overall, there would a medium (to high) cost to MS. Market restriction: The set up cost would be the same as under temporary market restriction (PO 6.2). The only difference is that in this case the listing is permanent. Assumption is that 50% of MS would implement this measure (as with 6.2). The running costs structure would be the same as under temporary restriction but the additional costs would be significantly higher as restricted substances would need to be monitored over their lifetime for industry's compliance and on which breaches would also need to be sanctioned. Costs would be applicable to 50% of MS. Some administrative costs are also envisaged for providing information to the EU on functioning of the permanent market restriction. Control measures: There would be no set up costs because MS can use the same system they implement in the case of illegal drugs. Similar running costs as under permanent market restriction but minor additional cost relating to involvement of wider scope of government agencies in implementation because of the added criminality aspect. Assumption is that 50% of MS implement this. Some administrative costs are also envisaged for providing information to the EU on functioning of the control under criminal sanctions. -- Final Report 139

146 Policy option 7.1 EU recommendation to submit substance to criminal law control measures or to recommend permanent market restriction measures Economic effects indirect cost increases Minor benefits: If administrative sanctions would be imposed, the MS would receive revenue from the breach of compliance. However, the cost of monitoring and sanctioning may not outweigh the financial benefits or they might balance each other out. Cost for 'soft' law enforcement on policing the permanent market ban (this could be done by customs and other regulatory enforcement authorities; police would be involved in hard core cases). Cost for 'hard' law enforcement on policing the permanent control under criminal justice system measures. Cost for judicial system in some, severe cases of breaches, of permanent market restriction and ban. --- Economic effects indirect costs reductions / benefits Relative high cost to industry leading to loss of revenue is expected, including direct costs from loss of revenue, indirect reputational costs etc. Potential decrease in government tax revenues in those MS where the industry is based. Some MS would be more affected than others. Reduction in healthcare costs (assuming that moderately harmful substances are under permanent restriction and the most harmful ones are prohibited), as well as related social costs (e.g. loss of productivity).the former is applicable to those MS that would have implemented the recommendation. Harm reduction is estimated at 2.5% Total 3- Social impacts Positive effects The availability of potentially harmful substances would be restricted in the EU. + + This is likely to reduce the possibility of physical and psychological harms (toxicity and overdosing, dependency, fatality etc.) greatly contribute towards prevention. Negative effects Minor negative impact. Permanent market restriction or control measures, - especially when disproportionate, might lead to increased criminalisation of especially young people. Total 1 + Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Practicability / feasibility Acceptability Enhanced consumer protection (Article 38), as a harmful NPS would be removed from the market. The freedom to conduct business (Art 16) would negatively be impacted, especially if the measures taken would not be proportionate with the risks posed by the banned substances. If some Member States would opt for a high level of criminalisation (e.g. prison sentence or substantial penalties), Article 49 on the principles of legality and proportionality of criminal offences and penalties might be negatively affected. Permanent market restriction or control measures, especially when disproportionate, might provide for an increase in the black market, a decrease in the quality of psychoactive substances and increased criminalisation. Due to the non-binding nature of the recommendation on permanent market restriction, not all Member States may implement the measure. This may lead to further market distortion as industry (producers, distributors and sellers) would have to work with different procedures in different MS. The feasibility will primarily relate to the financial consequences of the implementation and possibilities of effective implementation. The public acceptability of the measure is likely to be good as this measure would reduce the availability of harmful substances on the market, whilst offering different ways of achieving this. Some Member States may prefer an EU recommendation over a binding instrument. The industry distributing these substances is likely to have reservations on both the permanent market restriction and control measures, hence it would be important to ensure that only harmful substances are the subject of measures. Total Final Report 140

147 Table 6.22 EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures (PO 7.2) Policy option 7.2 EU decision to submit substance to criminal law control measures or to introduce EUwide permanent market restriction measures Same as above, but the permanent market restriction and control measures will be binding on Member States. Key assessment criteria Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score Key anticipated impacts Medium positive impact. Following an in-depth risk assessment, the mechanism would have the possibility to respond proportionately, according to the harm posed by the NPS. The most harmful NPS could be made subject to criminal control measures whilst for those representing moderate harm, market restriction measures could be put in place. The mechanism would strongly benefit from other policy options, such as the improved risk assessment tools and the networking of laboratories. High positive impact. Appropriate permanent market restriction or control measures would limit the availability of harmful NPS and hence reduce their negative health effects. It will be important to ensure that the measure is proportionate to the risk posed by the NPS, as banning multiple substances may have important unintended effects, as discussed further below. Medium positive impact. The option may help to reduce longer-term economic, health and social costs, for the reasons set out above and the measure will be implemented by all Member States. Some positive impact. Whilst contributing to better accounting for and regulating the NPS market, the measures would be reactive and it may take some time before they can be taken. The extent to which measures are proportionate will need to be carefully monitored so as not to trigger negative market dynamics (e.g. the fast appearance of other, possibly even more harmful, substances). Medium positive impact. The measures will be implemented by all Member States. However, based on previous experience, some countries will implement the measure with a substantial delay, which could mean that some displacement effects would continue to exist. Also, Member States could still implement measures in different ways, also with regard to the level of severity (e.g. fines, penalties and possibly prison sentence). No impact identified Rating Economic impacts Budgetary The cost is the same on all accounts as above in PO 7.1 but 50% higher, --- Final Report 141

148 Policy option 7.2 EU decision to submit substance to criminal law control measures or to introduce EUwide permanent market restriction measures consequences to as all MS must implement the measure. the EU, Member States and other stakeholders (e.g. industry) Economic effects The cost is the same on all accounts as above in PO 7.1 but 50% higher, --- indirect cost as all MS must implement the measure. increases Economic effects indirect costs reductions / benefits The healthcare cost and social costs reduction areas are the same as under option 7.1 above, but applicable to all Member States. Harm reduction is estimated at 5% Total 4- Social impacts Positive effects The effects would be similar as under PO 7.1 above but the positive social ++ impacts would be accentuated. This is due to the fact that MS would have harmonised their approaches. Negative effects Similar to PO 7.1 above. Possibly a marginal increase in negative impacts as -- the measure would be applied throughout the EU. Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Practicability / feasibility Acceptability Same as under PO 7.1 above, but applicable to all Member States. - Same as under PO 7.1 above, but applicable to all Member States. Displacement effects towards third countries may occur. The practicability and feasibility of the policy option is good, as the policy option offers a more measured package of measures from which the EU and Member ++ States can choose, rather than a black and white outcome. Most Member States already have similar measures in place at national level. Same as under PO 7.2 above. Some Member States may prefer EU recommendations than legally binding measures. ++ Total Table 6.23 EU prescribing the measure and outcome of control and risk management (PO 7.3) Policy option 7.3 EU prescribing the measure and outcome of control and risk management Same as above, but EU would prescribe the type of control and market restriction measures to be implemented by the Member States (in addition, their desired outcome). Both the implementation measures and outcomes would be prescribed by the EU. The option would be binding and would entirely harmonise approaches across the Member States. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the Medium positive impact, as under policy option 7.2 above. ++ Final Report 142

149 Policy option 7.3 EU prescribing the measure and outcome of control and risk management current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Total rating score High positive impact, as under policy option 7.2 above. +++ Medium positive impact, as under policy option 7.2 above. ++ Some positive impact, as under policy option 7.2 above. + Medium positive impact. The measures will be implemented by all Member States. However, based on previous experience, some countries will implement the measure with a substantial delay, which could mean that some displacement effects would continue to exist. No impact identified Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) In addition to PO 7.2 above, additional investments might be required to prescribe measures which at least appear to be feasible for all Member States. Additional research might be needed to determine this. Slightly lower administrative costs in comparison to PO 7.2, as all MS are undertaking the implementation in a uniform manner. The cost structure would be similar to PO 7.2. However, there would be additional costs to MS in ensuring that the set up meets the exact requirement from the EU. For several Member States, the set-up costs would thus be much higher than under PO 7.2 above, considering that MS would have to implement specific legislative measures/ using specific types of legislative instruments, Final Report 143

150 Policy option 7.3 EU prescribing the measure and outcome of control and risk management Economic effects indirect cost increases Economic effects indirect costs reductions / benefits which may not 'fit' well in their national systems and procedures, or which are highly unusual (possibly even requiring changes to procedural / substantive law and systems). The running costs structure would be similar to PO 7.2 above. However, there would be significant additional costs to MS in ensuring that the measures and outcomes are implemented in the manner prescribed by the EU. The administrative cost structure would be similar to PO 7.2 above. However, specific requirements on reporting would need to be followed which are likely to have a higher administrative burden. No additional loss in tax revenue to what would incur under PO 7.2 The set-up cost would be similar as under PO 7.2 but additional costs would involve regulatory authorities (and in specific cases law enforcement authorities) having to implement certain mechanisms to pursue the enforcement of permanent market restriction / control measures in order to deliver the desired outcomes. Same as under PO 7.2, a 5% harm reduction is envisaged. +++ Total 3- Social impacts Positive effects Same as under PO Negative effects Same as under PO Total 1+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Same as under PO 7.2. Possibly reduced risk of a breach of Article 49 on the principles of legality and proportionality of criminal offences and penalties, as measures would be harmonised both in terms of form and outcomes. 0 Same as under PO Other considerations Practicability / feasibility Acceptability The feasibility of the option is low considering that (some) Member States will not be able to implement certain types of legislative measures without having to make drastic changes to their national legal system and procedures. Furthermore, the fact that the Commission would prescribe a control or risk management measure is not proportionate, nor legally feasible. The EU prescribing both the implementation and outcomes regarding market restrictions is unlikely to be accepted by the MS, public authorities and industry. The costs of this would be very high and not proportionate with the types of problems regarding NPS and the results which would be obtained. Total Cluster 8: Education and awareness-raising As indicated in section 5, the following policy options were included within the Cluster 8: Policy Option Education and awareness-raising activities Policy Option Awareness raising and guidelines for better monitoring on import of NPS in the EU The assessments of these policy options are presented in Table 6.24 and Table 6.25 below. Final Report 144

151 Table 6.24 Education and awareness-raising activities (PO 8.1) Policy option 8.1 Education and awareness-raising activities Additional activities to make users aware of the risks associated with new psychoactive substances. This would include evidence-based drug prevention measures, including the provision of objective and factual information, awareness-raising about potential risks of using new psychoactive substances, even when these are sold legally, or with a specific focus on certain substances. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies No impact. 0 High positive impact. Education and awareness-raising will strongly contribute to making (young) people realise that legal does not necessarily mean safe, which is very important in the context of NPS. It would also help to make people quickly aware of particularly harmful NPS which have been made the subject of temporary or permanent market restriction or control measures. The activities will help citizens to make informed choices about the use of NPS and deter them from those which are particularly harmful. Medium positive impact. Educational and awareness-raising activities, especially when providing neutral, evidence-based information, will help to deter citizens from using in particular those NPS who are most harmful. Education and awareness-raising could have some effect on the market dynamics if they were influencing user choices towards less harmful NPS. No impact. 0 No impact Final Report 145

152 Policy option 8.1 Education and awareness-raising activities Total score rating Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) The budgetary consequences at EU will vary depending on the type and format of education and awareness-raising campaigns chosen, but overall, the costs for an EU-wide initiative can be substantial. The EU could opt, for example, for including a specific focus on NPS in already existing funding programmes, such as the European Action on Drugs, thus leaving it to national stakeholders, such as civil society, to develop activities. It could also develop and launch education and awareness-raising at central level or decentralise it by providing some funding, recommendations and guidelines to Member States Economic effects indirect cost increases Economic effects indirect costs reductions / benefits At national level, depending on the type and format of the initiative, some costs may be incurred for co-financing to set up and run the activities. No impact 0 As a result of education and awareness-raising, people may either be deterred from taking NPS or more carefully consider which ones they would take, thus leading to a reduction in health and social costs. There might also be some decrease in costs related to law enforcement and justice, if the option would help to reduce criminal behaviour, arrests, etc. Total 2- Social impacts Positive effects Positive effects would include more accessible drug prevention, communication ++ and information measures, and improved awareness-raising about the potential risks of the use and abuse of new psychoactive substances. Some positive impact could be envisaged in terms of user behaviour. These in turn would indirectly impact on the reduction of physical and psychological ham relating to the use of NPS, as well as have wider social and economic benefits. Negative effects None identified 0 Total 2+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations Practicability / feasibility Acceptability This option would have some influence on enhancing consumer protection (Art 38) through a preventative educational measure. No direct impact identified. Indirectly, the policy option could help reduce criminalisation of young people. The practicability of the option is very good, but its feasibility will depend on the extent to which financial resources can be allocated to the initiatives, both at EU and national level. It may also be challenging to develop an EU-wide harmonised approach to prevention, considering the different national views on new psychoactive substances and drugs in general, ranging from fairly liberal to very restrictive. The political and public acceptability are very good as this is a preventative measure. Total Final Report 146

153 Table 6.25 Awareness-raising and guidelines for better monitoring on import of NPS in the EU (PO 8.2) Policy option 8.2 Awareness-raising and guidelines for better monitoring on import of NPS in the EU This proposal would include developing EU-wide awareness raising activities and guidelines for Customs officials in the Member States (and targeted third countries) to make these authorities aware of the importance of notifying new psychoactive substances. In addition, these activities could be extended to relevant companies, e.g. couriers and private postal services, transport firms etc. Key assessment Key anticipated impacts criteria Policy objectives Rating To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Medium positive impact. Awareness-raising activities would improve the notification of new substances emerging on the market and contribute towards a more timely and effective response to the identification of new psychoactive substances. Some positive impact, since the option would allow for a more timely and effective response to NPS, thus indirectly contributing to reducing potential harm to public health. Some positive impact, since the option would allow for a more timely and effective response to NPS, thus contributing to reducing economic and social costs. Medium positive impact. The policy option would help to better map the market, as emerging NPS would be quickly identified. This would also improve the possibility to regulate the market in case of harmful substances. Some positive impact. It is expected that more NPS would be notified at EU level, allowing for a better and timelier EU response. This may help to reduce Member States taking disjointed measures. No impact 0 Final Report

154 Policy option 8.2 Awareness-raising and guidelines for better monitoring on import of NPS in the EU Total rating 7+ score Economic impacts Budgetary consequences to the EU, Member States and other stakeholders (e.g. industry) Low set-up costs are envisaged to the EU budget for organising awarenessraising activities or drafting guidelines for improved monitoring of imports with regard to new psychoactive substances. Some administrative cost might be involved in terms of monitoring compliance. Medium set-up and running costs are envisaged to Member States budgets and the budgets of targeted third countries. These could include costs associated with initial staff training staff on the guidelines for import of NPS, follow-up trainings or updates, identifying substances which may require notification and notifying these. - - Economic effects indirect cost increases Economic effects indirect costs reductions / benefits Set-up and running costs are also expected for companies such as couriers and private postal services, transport firms etc. with regard to the identification of NPS which may require notification and their referral to appropriate authorities. Considering the substantial quantities of goods which pass the borders every day and which are transported by couriers and other transport services, substantial time could be spent on monitoring NPS. It is however unlikely that, in reality, this would happen. Some positive, though highly indirect, impact as the option may contribute to NPS causing, in particular less harm and hence less health and social costs. Total 4 - Social impacts Positive effects The option would contribute to a better functioning of the EU mechanism for ++ notifying new psychoactive substances and tackling the issue as a whole, thereby indirectly contributing to reducing potential societal harm and strengthening prevention. Negative effects None identified 0 Total 2+ Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts This option would have some indirect influence on enhancing consumer protection (Art 38) by contributing to overall drug prevention efforts No impact identified 0 Other considerations Practicability / feasibility Acceptability The practicability of the option is very low, considering the huge quantities of goods which pass the borders and/or are transported every day. It is unlikely that customs authorities, couriers, postal services and transport firms would have the time to control whether these potentially contain NPS which in addition are still legal on top of their other monitoring obligations (i.e. of illicit goods and substances). Whilst the policy option appears to be a good and sensible idea in principle, the practical implications will also influence the extent to which political stakeholders will consider it acceptable. Total Final Report 148

155 7 Comparison of the options and considerations on possible preferred options This section of the Report compares the assessments of the policy options presented in section 6 above. This will enable the identification of the preferred policy option. 7.1 Comparative analysis of the policy options This section provides a comparative assessment of the direct and indirect impacts, risks and trade-offs of the policy options elaborated and assessed in sections 5 and 6. On the basis of this analysis, the second part of this section presents a full outline of the preferred policy option. Table below provides a comparative overview of the qualitative assessment of the scoring of the policy options. The sections that follow provide an analysis of the relative merits of the different options. Final Report 149

156 Number and name of the policy options Objectives Economic impacts Social impacts Fundamental rights impacts Unintended impacts Practicability/ feasibility Acceptability Status Quo Discontinue the Council Decision Policy option 1.1 Establishment of EU illicit drugs risk reference list of harms Policy option 1.2 Risk assessments by industry Policy option 1.3 Market authorisation with restrictions Policy option 2.1 Introduction of common definitions Policy option 2.2 Improved coordination and referral to other EU legislation / mechanism Policy option 3.1 Improved conditions for Early Warning System (EWS) Policy option 3.2 Joint Report to include early toxic screen Policy option 3.3 Improved conditions for Joint Reports: Decision powers regarding Joint Reports Policy option 4.1 Development of common criteria and guidelines for proactive monitoring Policy option 4.2 Introduction of a proactive monitoring system Policy option 4.3 Introduction of a post-risk assessment monitoring system Overall total Final Report 150

157 Policy option 4.4 Introduce additional standardised tools and databases for risk assessments Policy option 4.5 Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA Policy option 4.6 Establishment of an EU research laboratory for new psychoactive substances Policy option 5.1 Generic approach by group of substances Policy option 5.2 Analogue approach by group of substances Policy option 6.1 Urgency Joint Report procedure for toxic substances Policy option 6.2 EU recommendation to introduce temporary emergency measures Policy option 6.3 EU decision to introduce temporary emergency measures Policy option 6.4 Extending Risk Assessment period during temporary restriction Policy option 7.1 EU recommendation to submit substance to criminal law control measures or to recommend permanent market restriction measures Policy option 7.2 EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures Final Report 151

158 Policy option 7.3 EU prescribing the measure and outcome of control and risk management Policy option 8.1 Education and awareness-raising activities Policy option 8.2 Awareness-raising and guidelines for better monitoring on import of NPS in the EU Final Report 152

159 7.1.1 Cluster 1: Preparing to allow (some) NPS on the market As shown in the comparative summary above, the three policy options included in Cluster 1, namely 1.1 Establishment of EU reference list on harms associated with licit and illicit psychoactive substances, 1.2 Risk assessments by industry and 1.3 Market authorisation each receive a positive scoring. Policy options 1.1 and 1.3 share the highest score, with in particularly 1.3 having most impact on the policy objectives. However, the latter is highly controversial, with both the acceptability and the practicability being very low. It is highly unlikely that Member States will, in the short to medium term, reach consensus on truly authorising legal highs, i.e. allowing certain NPS on the market because they are considered to represent an acceptable level of harm, comparable to alcohol and tobacco. Policy option 1.2 cannot be implemented without the existence of a market authorisation mechanism, as proposed under policy option 1.3. Also, policy option 1.2 is highly controversial, with many stakeholders doubting the extent to which industry could be trusted with undertaking risk assessments. Finally, the policy option would still require a monitoring mechanism to verify and validate the risk assessments, which would represent a significant cost. Policy option 1.1 EU reference list on harms associated with licit and illicit psychoactive substances receives a high score and would be considered acceptable, provided that it would not be linked to policy options 1.2 and 1.3, in the sense that it would not (directly) lead to accepting the potential authorisation of NPS. In the longer term, however, the policy option could also pave the way for discussions on possible authorisation. It is therefore proposed to include policy option 1.1 in the preferred policy option, essentially because it will allow taking better decisions regarding type of control measures, or not to take control measures on a specific NPS Cluster 2: Basic elements Both policy options, namely 2.1 Introduction of common definitions and 2.2 Improved coordination and referral to other EU legislation / mechanisms, included in this cluster receive overall positive scorings. In fact, they are both important for the proper identification and handling of NPS. In particular policy option 2.2 will help to reduce the risk that harmful NPS go undetected and make sure that the most appropriate legislation or mechanism is used to respond to the substance. Policy option 2.1 would ensure a more harmonised interpretation, and possibly a more harmonised approach to, NPS. For this reason, it is proposed to include both policy options in the preferred policy option Cluster 3: Improving Early Warning System and Joint Report procedures Cluster 3 includes three policy options, namely 3.1 Improved conditions for the EWS, 3.2 Joint Report to include an early toxic screen and 3.3 Improved conditions for Joint Reports: Decision powers regarding Joint Reports. Policy options 3.3 and 3.2 receive overall positive scorings and are considered to be uncontroversial. Whilst policy option 3.3 would in particular benefit the efficiency of the overall mechanism, allowing for fast decision making, policy option 3.2 would improve the effectiveness of the mechanism, by contributing to a more complete Joint Report. Both policy options would be very important in particular for the implementation of temporary emergency measures as envisaged as part of Cluster 5. Policy option 3.2 would benefit from the strengthened research capacity of the mechanism, as envisaged under Cluster 4. Based on their scoring, it is suggested that both are included in the preferred policy option. Policy option 3.1 receives a less positive overall scoring, specifically also because of its possible low feasibility. Considering the preferred options in this cluster, as well as those indicated under Clusters 4 and 5, this policy option is also less relevant Cluster 4: Research and analytical capacities on new psychoactive substances Cluster 4 includes five policy options, two related to proactive actions, namely 4.1 Development of common criteria and guidelines for proactive monitoring, 4.2 Introduction of a proactive monitoring system, one aimed at improving monitoring after a risk Final Report 153

160 assessment, namely 4.3 Introduction of a post-risk assessment monitoring system and three focusing on improving research and analytical capacity in general, namely Introduce additional standardised; tools and databases for risk assessments, 4.5 Networking research facilities and forensic laboratories and 4.6 Establishment of an EU research laboratory for new psychoactive substances. Policy options 4.5 and 4.6 focus on achieving the same outcome, but through different ways, namely either through a networked or a central function. Policy option 4.5 receives a highly positive scoring and is more costefficient than policy option 4.6. For this reason, it is suggested to include policy option 4.6 in the preferred policy option. Policy option 4.4 can be considered an important accompanying measure of policy option 4.5 and should, for that reason, be included too. Policy options 4.2 and 4.3 also receive positive scores. However, both imply fairly high costs specifically at the level of the Member States, with the benefits being less evident, or less direct. Their acceptability is also deemed to be lower, especially considering the economic crisis. For this reason, it is proposed not to include them in the preferred policy option. However, considering the clear benefits of proactive monitoring, it is still suggested to include policy option 4.1, so that Member States who do wish to engage in this form of monitoring would be encouraged to use a common approach, which would strongly favour also the capacity of the EU mechanism Cluster 5: Addressing new psychoactive substances individually or in a group As shown in the comparative summary table, the policy option 5.1 with a generic approach to risk assessment was rated higher than the option 5.2 with analogue approach to risk assessment. In reality neither of these approached would substitute individual risks assessment, but they provide certain benefits in understanding similarities within and between groups of substances. It was judged that the generic approach better addressed the policy objectives, was more practicable and also seemed acceptable to stakeholders, in comparison to the analogue approach. In addition, only a minor share of the Member States has an analogue approach to market restriction and control measures concerning NPS. Any EU recommendation or decision which would emerge on this basis could thus be challenging to implement Cluster 6: Temporary emergency measures Of cluster 6 the highest score was given to the option 6.3 relating to the EU decision to introduce temporary emergency measures. This option scores very high in addressing the policy objectives, and all the other options in the cluster received a lower scoring in this regard. The option is also considered acceptable to stakeholders and is feasible, although with some negative economic impacts but without unintended consequences. Similar to this option (with a lower overall score) was the option 6.2 EU recommendation to introduce temporary emergency measure. However, this would be less effective option as not all Member States would voluntarily implement the measure which would leave disparity in the EU regarding the emergency measures that could be taken a potentially dangerous new psychoactive substance. This also scored considerably lower in meeting the policy objectives. Both the other options within the cluster, namely 6.1 urgency Joint Report procedure for toxic substances and 6.4 extending Risk Assessment period during temporary restriction, closely support the temporary emergency measure, and received similar overall scoring. Both the options address achieving the objectives almost equally well as well as seem highly acceptable and feasible Cluster 7: Final decision on a new psychoactive substance Of the policy options in cluster 7, option 7.2 EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures received the highest score. The option scored particularly high in meeting the policy objectives and in terms of its practicability and feasibility. It was rated costly in terms of economic impacts and with respect to unintended impacts. Similar to this option (with an overall lower score) was the EU recommendation to submit substance to criminal law control Final Report 154

161 measures or to recommend permanent market restriction measures (option 7.1). The latter option scored considerably lower with respect to meeting the policy objectives and was considered less practicable, even if in other regards these options scored similarly. The latter option would also be a far less effective intervention as not all Member States would implement the measure, meaning that market restriction and criminal control of new psychoactive substances would continue to be disjointed in the EU. The option 7.3 regarding EU prescribing the measure and outcome of control and risk management scored high on meeting the policy objectives but it would not be feasible or acceptable to the Member States as they would entirely need to adapt to measures prescribed by the EU. Its overall score was same as the EU recommendation for permanent market restriction and criminal control measures as regards to new psychoactive substances Cluster 8: Education and awareness-raising Of the two options under cluster 8, option 8.1 Education and awareness-raising activities scored considerably higher than awareness-raising and guidelines for better monitoring on import of NPS in the EU (option 8.2). Although both scored equally high in meeting the policy objectives, social impacts and fundamental rights, the latter option would have high negative economic impacts and its implementation would not be practicable, with its acceptability to stakeholders also being questionable. Neither was judged to have unintended impacts. 7.2 Considerations on the package of policy options which could be included in the preferred policy options The preferred policy option would involve a combination of options included under each of the 8 clusters discussed in sections 5 to 6 above. These are those options that received high assessment scores and/or were considered necessary for the inclusion in a comprehensive package of options. From cluster 1, it is considered important to include the option regarding the establishment of an EU reference list on harms associated with licit and illicit psychoactive substances as this would enable the classification of new psychoactive substances according to their harm and risks. Concerning cluster 2, both the introduction of common definitions and improved coordination and referral to other EU legislation / mechanism would be essential to include in order to ensure that new psychoactive substances are accurately identified, appropriately considered and effectively dealt with. As to cluster 3, it is proposed that options to improve the content, conditions and decision making regarding Joint Reports are included in the preferred option in order to improve the response capacity and information at an early stage. These options would be: Joint Report to include early toxic screen, improved conditions for Joint Reports: Abolishing obligation to justify and improved conditions for Joint Reports: decision powers regarding Joint Reports. From cluster 4 the following policy options are proposed for inclusion: introduce additional standardised tools and databases for risk assessments and networking research facilities and forensic laboratories. The standardised tools and databases would enable more informed and comprehensive risk assessments at EU level, whereas the networking of research facilities and forensic laboratories would improve the capacity to rapidly produce forensic, toxicological and pharmacological data on new psychoactive substances and conditions for investigating the potential harms of a substance and assessing their risks. The development of common criteria and guidelines for proactive monitoring is also proposed for inclusion so that Member States which undertake proactive monitoring would benefit from a common approach. Although individual risk assessments are likely to remain essential and valid when assessing the risks of new psychoactive substances, in many cases, generic approach by group of substances might be relevant in order to better account for the effects that groups of similar substances might have and improve the capability to foresee risks of related substances. Accordingly, it is proposed that this option is included to the preferred option from cluster 5. Final Report 155

162 Several measures from cluster 6 are considered to have beneficial consequences for assessing, understanding and limiting the potential risks arising from new psychoactive substances. The following measures are proposed for inclusion: urgency Joint Report procedure for toxic substances, EU decision to introduce temporary emergency measures, and extending Risk Assessment period during temporary restriction. The option from cluster 7 comprising of EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures is proposed to be included in the preferred option. This option would allow for a comprehensive control of substances that pose serious risks to human health to be banned either via permanent market restriction or through subjecting these new psychoactive substances to criminal control measures. The permanent market restriction is essential counterpart to the criminal control measure as a lighter and quicker measure to permanently exclude a new psychoactive substance from the EU market. Finally, in the context of all the above measures, it will be also important to include education and awareness-raising activities from cluster 8. It is essential that especially young people are educated on the possible risks of consuming new psychoactive substances which have not officially been authorised for safe human consumption. It is essential that citizens are provided all the information in order to make educated decisions on substances they consume and the risks that are related to this. Table 7.1 below shows the key components to be included within the preferred policy option, based on the considerations above. Final Report 156

163 Table 7.1 Key elements of the preferred policy option Cluster Options to be included in the PPO Brief description Cluster 1: Preparing to allow (some) NPS on the market Cluster 2: Basic elements 1.1 Establishment of an EU reference list on harms associated with licit and illicit psychoactive substances This would include regular assessment and updating of the risks and effects of licit and illicit substances, also for reference purposes for new psychoactive substances. Over time, a reference list of harms of more or less harmful psychoactive substances is created, and when information on certain new psychoactive substances is obtained, these can be included in the system. The system is relevant for comparison between psychoactive substances but also to inform the public about risks and develop prevention approaches. It would support the development of appropriate control (criminal justice) and market regulation measures, as well as prevention measures 2.1 Introduction of common definitions Introduction of a definition of new psychoactive substances and legal highs, which should close the gaps between different types of EU legislation so that all psychoactive substances that are not identified as medicine, food, chemical or illicit drugs are covered (e.g. bath salt which has the clear intention to be used as a drug). 2.2 Improved coordination and referral to other EU legislation / mechanisms This proposal would include increased coordination and referrals within the legal instruments to other relevant EU legislation / mechanisms, during pre-risk assessment stage. This concerns for example the food safety mechanism run by EFSA and the pharmaco-vigilance system run by EMA. The main purpose would be to ensure that new psychoactive substances are swiftly detected in the supply chain and to avoid that these are not considered by any of the existing mechanisms. In addition, the proposal would help to identify other EU legislative instruments which could possibly be used in order to control new psychoactive substances. In addition to possibly making legislative changes to the Council Decision, the option could be accompanied by practical guidelines, memoranda of understanding, etc. Cluster 3: Improving Early Warning System and Joint Report procedures Cluster 4: Research and analytical capacities on new psychoactive substances 3.2 Joint Report to include early toxic screen The Joint Report would already include a first screening of the substance on toxicology. This would also allow for the launching of the urgency procedure. This is linked to the option on introducing temporary emergency measure under cluster Improved conditions for Joint Reports: Decision powers regarding Joint Reports 4.1 Development of common criteria and guidelines for proactive monitoring The Commission, in addition to the Council, EMCDDA and Europol could also request a Joint Report Specific criteria and methodological guidelines would be developed for the proactive monitoring of new psychoactive substances which would benefit those Member States that are already undertaking this type of monitoring. These would help the Reitox network members and Europol National Units to undertake any proactive monitoring according to Final Report 157

164 Cluster Options to be included in the PPO Brief description common procedures and criteria, which substances to select for further examination (e.g. thresholds), etc. The current monitoring system used by EMCDDA could be further elaborated for this purpose. 4.4 Introduce additional standardised tools and databases for risk assessments 4.5 Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA This proposal would introduce additional common methods, tools and instruments for risk assessments, especially concerning new psychoactive substances for which very little scientific on their effects is available. With respect to prevalence studies, this would, for example, include the development of standard sets of survey questions (which require a minimum of adaptation to tailor it to a different substance) for surveys to users and organisations working with potential users. The proposal could also include the development of a common, EU wide database of young people and relevant organisations in the field, who are in principle willing to respond to surveys (e.g. similar to the European Business Test Panel), so that risk assessments can involve a large group of respondents within a relatively limited time period. Under this option, the EU's research and analytical capacity on new psychoactive substances would be improved. Its capacity to produce rapidly forensic, toxicological and pharmacological data on new psychoactive substances, to support and strengthen the collection of information on the potential harms of a substance and assess its risks would be enhanced. Cluster 5: Addressing new psychoactive substances individually 5.1 Generic approach by group of substances This would be done by supporting structural collaboration European research institutions (including the Joint Research Centre JRC), in coordination with the EMCDDA, and promote cooperation between the EMCDDA and forensic laboratories' networks, such as the European Network of Forensic Science Institutes. This would facilitate the development and sharing of forensic information and research findings on new psychoactive substances. This network would also support the development of systems to collect epidemiological data (including the standardisation of survey methodologies, protocols and data collection methods), help disseminate information (including on prevention) and reassess the harms of substances. It would help to develop common EU criteria and guidelines for the proactive monitoring of the market (internet monitoring, test-purchasing), which national authorities will be invited to implement voluntarily. This option would allow for assessing the risks and making decisions on several new psychoactive substances at the same time, based on their similar chemical structure. The Final Report 158

165 Cluster Options to be included in the PPO Brief description or in a group risk assessment could start with an individual substance, and when appropriate also considering their generic context, providing, where possible, for an intelligent grouping of substances (i.e. reviewing the possible emergence of chemically related substances and their anticipated risks). But since substances that are chemically similar can have very different effects and pose different risks, the generic risk assessment would in practice mean assessing the risks of one substance and extrapolating results to a group of related substances (without assessing their particular risks). Cluster 6: Temporary emergency measures Cluster 7: Final decision on a new psychoactive substance 6.1 Urgency Joint Report procedure for toxic substances 6.3 EU decision to introduce temporary emergency measures 6.4 Extending of Risk Assessment period during temporary restriction 7.2 EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures As part of the Early Warning System, specific criteria would be developed to activate an urgency procedure for preparing a Joint Report for new substances which appear to have a high level of toxicity and / or on which initial reports on adverse health consequences raise particular concerns in several Member States. On the basis of the results of the joint report produced by the EMCDDA and Europol, the Commission can decide to oblige the Member States to introduce emergency measures to restrict the production, trade and sale of a new psychoactive substance that poses immediate concerns. This measure only concerns the use of the substance for its psychoactive effect; it will not restrict its availability for research and legitimate industrial uses. If the risk assessment shows that the substance poses severe risks, the emergency measures will be made definitive by scheduling the substance on a restricted substances list. The purpose of the measure is to ensure that the substance can be assessed thoroughly without consumers being exposed to its potential harms until its actual risks are identified. The emergency measures should have a limited duration (maximum one year, renewable once) and should automatically expire after that time. To ensure rapidity of action, this decision will be taken through a delegated act. The temporary restriction measure of a harmful new substance, would allow for more time for the Risk Assessment to explore in detail its harm Under this scenario, once the risk assessment is concluded, the EU would have different alternatives for action. If the risk assessment proves that a new psychoactive substance poses severe risks to health and safety of individuals, the Commission can decide to add the substance to a list of substances submitted to criminal control measures across the Final Report 159

166 Cluster Options to be included in the PPO Brief description EU (by means of a delegated act). However, if the risk assessment proves that a new psychoactive substance has a moderate or low risk to health and safety, the Commission can recommend to the Member States to introduce market measures permanently restricting the production, trade and sale of the new psychoactive substance, without restricting availability for research and legitimate industrial uses (by means of a delegated act). If the Commission decides that no further measures are necessary, it should justify why. Possible market restriction measures could include: Permanent market restriction prohibiting import / export Permanent market restriction, prohibiting manufacture, production, trade, distribution and sale Possible control measures could include: Permanent control, making import/export, manufacture production, trade, distribution and sale a criminal offence Permanent control making possession an offence. The above measures would not restrict the availability of new psychoactive substances for research and legitimate industrial uses. Cluster 8: Education and awareness-raising 8.1 Educational and awareness-raising activities Additional activities to make users aware of the risks associated with new psychoactive substances. This would include evidence-based drug prevention measures, including the provision of objective and factual information, awareness-raising about potential risks of using new psychoactive substances, even when these are sold legally, or with a specific focus on certain substances. Final Report 160

167 7.2.2 Assessment of the preferred policy option This section presents the qualitative and quantitative assessments of the Preferred Policy Option (PPO). The qualitative assessment summarises the impacts with respect to the following criteria: Achieving the policy objectives; Social impacts; Impacts on fundamental rights; Unintended impacts; Practicability / feasibility; and Acceptability of the preferred option The quantitative assessment values the costs and benefits of the preferred option by weighing up: potential reduction of harm associated with the preferred policy option (for which detailed estimates are presented in Annex 8); and the likely scale of costs associated with the preferred policy option (for which detailed cost estimates are presented in Annex 8). Table 7.2 below provides an overall qualitative assessment of the preferred policy option. Final Report 161

168 Table 7.2 Qualitative assessment of the preferred policy option Key assessment criteria Key anticipated impacts Policy objectives To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful NPS To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new Overall, the preferred policy option would have a medium positive impact on the achievement of the policy objective to improve and increase the scientific capacity of the current mechanism, because it introduces a number of elements which will ensure that the response is effective e.g. the EU reference list on harms associated with licit and illicit psychoactive substances will allow for the mechanism to categorise NPS and come forward with a response which is proportionate to the risk they pose; the additional standardised tools for risk assessment will improve the consistency and quality of the risk assessment; Efficiency will also be improved, as there will be greater coordination with other EU instruments that will reduce the likelihood of overlap of activities (thus making the mechanism more efficient). This increased coordination will also make it easier to detect substances and to assign the most appropriate mechanism (e.g. pharmacovigilance or the EWS, etc) to address them. The Urgency Joint Report and temporary emergency measures will also allow the Commission to respond with greater speed and efficiency to harmful NPS. By including an early toxic screen in the Joint Report, it will be easier to anticipate harmful NPS, as it will be possible to identify substances earlier and to hence provide a faster response to potentially harmful NPS. As the risk assessment would anticipate the emergence of substances which are highly similar in chemical structure (generic approach), the possible risks associated with future NPS can to some extent - be anticipated and possibly averted. The overall scientific (forensic and research) capacity and efficiency of the mechanism would be greatly improved through supporting structural cooperation between existing EU research institutes and promoting further cooperation between the EMCDDA and ENFSI. Such collaboration could also be highly useful for the implementation of many of the other options, such as work on the EU reference list on harms associated with licit and illicit psychoactive substances, proactive monitoring and the use of improved risk assessment tools. Overall the preferred option would have a medium positive impact on the policy objective to prevent and/or reduce the potential risks to health of harmful NPS. On the one hand, some of the more operational features of this policy option (such as improvement of coordination with other EU instruments, and those aspects related to the Joint Report procedures) would have only a negligible or low positive impact, because although they may improve the efficiency and the effectiveness of the system s processes, they do not have a direct impact on preventing users from consuming harmful NPS. By contrast, the introduction of temporary emergency measures and the EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures - would limit the availability of harmful NPS and hence reduce their negative health effects. Education and awareness-raising activities will help citizens to make informed choices about the use of NPS and deter them from those which are particularly harmful; it would also increase awareness of any NPS that had been recently submitted to control measures, to ensure that users do not unknowingly engage in illegal activities. The preferred option is likely to have a medium positive effect on reducing the economic, health and social costs generated by harmful new psychoactive substances, because it will improve the functioning of the system and have an impact on reducing harm caused by NPS (see above) and, therefore, indirectly reduce costs. The increased collaboration between research (++) (++) (++) Final Report 162

169 psychoactive substances To better account for, and where necessary, regulate the market dynamics of new psychoactive substances in a way proportionate to the risk institutes and laboratories would contribute to increased knowledge on psychoactive substances which would help to make better informed decisions concerning urgency, market restriction and control measures. These would in return contribute to reduce economic, health and social costs. The EU Decision on temporary emergency measures would have a medium positive impact on reducing harms, as all Member States would be required to implement the temporary measure and this would decrease the likelihood of cross-border issues and their ensuing costs. The preferred option would also have a medium positive effect on better understanding and to some extent regulating the market dynamics of NPS, whilst introducing some safeguards to help policy decisions-makers measure the proportionality of their market-related policies. First, the introduction of temporary emergency measures, the revised approach to risk assessments (which would anticipate market dynamics by identifying chemically related substances which may be introduced as soon as a substance is subjected to market restriction or control measures) and the EU decision to introduce EU-wide permanent market restriction measures will give more powers to the Commission to regulate the market; however, the extent to which measures are proportionate will need to be carefully monitored so as not to trigger negative market dynamics (e.g. the fast appearance of other, possibly even more harmful, substances). In these cases, elements such as the EU reference list on harms associated with licit and illicit psychoactive substances which will categorise substances by their level of potential harm will support policy decision-makers in ensuring that market restrictions are proportionate. Similarly, more precise definitions related to NPS used by all Member States will improve efficiency. Other elements such as the development of common criteria and guidelines for proactive monitoring, which will support a more effective exchange of information (on market dynamics amongst other information) between Member State and some of the standardised tools for risk assessment such as an EU survey tool, which may be useful for improving understanding of user preferences and any new substances appearing on the market, will increase policy decision-makers understanding of the market. Structural collaboration between research institutes could also increase overall understanding of the market dynamics of NPS. In addition, all aspects of the preferred option which increase the speed with which the mechanism can identify and analyse the harms of NPS (e.g. the early screening of toxicology) means that policy decision-makers are better equipped to carry out early intervention with regard to the markets. Education and awareness-raising could have some effect on the market dynamics if they were influencing user choices to abstain from the use of NPS or towards using less harmful NPS. At minimum this intervention would allow users to become educated with respect to risks and harms associated with NPS, upon which decisions can be based. (++) To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States The preferred option will have a medium positive impact on avoiding/reducing unintended effects caused by differences in approached to NPS between Member States. The EU reference list on harms associated with licit and illicit psychoactive substances will ensure greater consistency between Member States in classifying the harm of different substances. The introduction of common definitions will also increase harmonisation. The preferred option would also require all Member States to implement EU Decision on temporary emergency measures and the EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures, which will increase (++) Final Report 163

170 To eliminate regulatory grey zones between EU instruments and increase synergies consistency in response to those NPS subject to EU-wide concern. However, the elements of the preferred option do not fully address the unintended effects from disjointed approaches by Member States, as they leave much of the regulation of NPS as a national competence. This however is recommendable as Member States also have localised concerns with certain NPS inside their territory, which do not cause an EU-wide concern. The preferred option would have a high positive impact on eliminating regulatory grey zones between EU instruments and increasing synergies. Above all, improved coordination and referral of new psychoactive substances to relevant EU legislation (e.g. EMA pharmaco-vigilance system, RASFF by EFSA etc.) would go a long way to reduce grey zones between the instruments and not allow substances to go undetected by any of the mechanisms. The introduction of common definitions would also help to reduce the gaps between the different types of EU instruments which might be relevant for dealing with these substances (e.g. EU illicit drug legislation, EMA pharmaco-vigilance system, EFSA food safety mechanism etc.). Early toxicology screening when combined with other measures (e.g. improved coordination between EU instruments) would mean the instruments to which a substance is relevant (i.e. pharmacovigilance, EWS, etc.) can be identified at an earlier stage. Total rating score Medium to high positive impact (++) (+++) Economic impacts Budgetary consequences to the EU, Member States and other stakeholders Overall, the preferred option is likely to have medium negative budgetary consequences on the EU, Member States and other stakeholders. The most costly elements of the preferred option for the EU would include the facilitating of structural collaboration between research institutes, forensic laboratories and the EMCDDA, funding provided towards EU-wide education and awareness raising activities regarding NPS and to an extent costs relating to the establishment of EU reference list on harms associated with licit and illicit psychoactive substances and introduction of standardised tools and databases for risk assessments. There will be medium to high costs for Member States in implementing EU decision on temporary emergency measures and the EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures. Education and awareness-raising activities will also create costs for Member States. To an extent some costs are also incurred through the structural collaboration activities between research institutes, forensic laboratories and the EMCDDA and through the introduction of additional standardised tools and databases for risk assessments. Other stakeholders who will incur costs as a result of the implementation of the preferred option, include forensic and research institutes that may incur a medium negative cost in adapting their working processes to become part of the network of laboratories (in addition to the EU funding they will receive). The preferred option will also introduce some minimum cost-saving e.g. by improving the efficiency of procedures for launching a Joint Report. (- -) Economic effects indirect cost increases Overall, the preferred option is likely to have noticeable negative impact with respect to indirect cost increases, as it is the case with any measure that includes control and prohibition requiring enforcement. This is clear from the types of cost that are involved in the enforcement of illicit drug laws for instance. (--) Final Report 164

171 There would be indirect costs increases regarding the law enforcement costs and the costs to judicial system. These cost increases would result in response to EU Decision on Temporary emergency measures and the EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures. Industry will also incur costs from substances being banned or otherwise restricted, as this would reduce their revenue and possibly overall market value. However, it is unlikely that the legitimate EU industry would be impacted as a consequence, as NPS do not generally have a legitimate use in industrial process. Thus far, two NPS have been identified as having other legitimate uses; GBL as an industrial solvent and desoxy-d2pm which has been used has as a chiral agent in NMR analysis. None of the NPS have also been registered as medicine, even if in some cases they are controlled in Member States under medicine legislation because of their psychoactive effect. This however does not mean that they are considered as a medicinal product, rather than a control under the legislation is convenient in certain circumstances. Economic effects indirect costs reductions / benefits Overall, the preferred policy option will have a medium positive impact on reducing indirect costs / bringing benefits. It is estimated that the option will reduce the total harm associated with NPS by a quarter. This is primarily though the effects of education and awareness-raising activities and the introduction of temporary emergency measures and permanent market restriction, including possibility for criminal control in the case of severely harmful NPS. As the preferred option introduces a number of measures to make risk assessment more effective (i.e. introducing additional standardised tools and databases for risk assessments and extending the time for risk assessment when a substance is under temporary measure), this will allow the EU to take more appropriate market restriction and control measures, which would help to reduce healthcare costs and possibly productivity losses. As a result of education and awareness-raising, people may either be deterred from taking NPS or more carefully consider which ones they would take, thus leading to a reduction in health and social costs. There might also be some decrease in costs related to law enforcement and justice, if the option would help to reduce criminal behaviour, arrests, etc. In addition, the collaboration between research institutes, forensic laboratories and the EMCDDA would allow the EU to take more timely and appropriate market restriction and control measures, which would indirectly lead to cost reductions in healthcare and, possibly, productivity losses. Moreover, on the condition that appropriate market restriction measures are taken, law enforcement / judicial costs may be reduced somewhat as a result of more targeted control measures regarding the perceived harmfulness of the given NPS. (++) Total The economic costs and benefits are rather balanced with both medium costs and benefits (-/+) Social impacts Positive effects The preferred option would overall have medium positive social impacts. The generic approach would indirectly reduce physical and psychological harm, especially because the option would anticipate the emergence of additional substances and anticipate putting appropriate measures in place beforehand, thus contributing to prevention of potential harm of substances. The EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures would also have a notable impact. Finally, education and (++) Final Report 165

172 Negative effects Total awareness-raising would have a direct impact on user behaviour which would bring wider social impacts though education of harmful; effects of NPS. The EU reference list on harms associated with licit and illicit psychoactive substances and the collaboration between research institutes, forensic laboratories and the EMCDDA would also go some way to improving understanding of harm. Moreover, the improved coordination and referral to other EU mechanisms will ensure a higher coverage of potentially harmful NPS, through better involvement of the various EU mechanisms. Overall the preferred option would have negligible negative effects. While the generic approach could risk the inclusion of substances which do not have psychoactive effects, which in turn might lead to some unnecessary control and criminalisation of users; the EU decision on temporary emergency measures as well as other measures (see above) are likely to outweigh this negative effect. Medium positive impact (0) (++) Impacts on fundamental rights E.g. Article 16 Freedom to conduct a business, Article 38 Right to consumer protection Unintended impacts Other considerations The preferred option is likely to have a negligible impact on most fundamental rights, except for Article 38 (the right to consumer protection), on which it will have a medium positive impact. With regard to consumer protection, most notably, EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures would have a noticeable impact. In addition, collaboration between research institutes, forensic laboratories and the EMCDDA would contribute to ensuring a timelier and more accurate response which will reduce harm to health, hence enhance the rights as regards consumer protection. The education and awareness raising activities would strengthen consumer protection (Art 38) as there would be better understanding of the problems related to NPS (e.g. legal does not mean safe ) and associated risks to health/ society etc. Improved coordination and referral between EU instruments would in general strengthen consumer protection (Art 38) in a number of fields (e.g. drugs/ medicines/ food/ chemicals etc. legislation). More robust risk assessments would lead to better informed decision making on market restriction and control measures which will improve consumer protection. As a result of the introduction of an EU generic approach to risk assessment, users would be made aware of the potential harmful effects of a group of NPS. The policy option would also prevent the appearance of more harmful, highly similar substances. It is also worth noting that the preferred policy option is not likely to have an impact on freedom to conduct business as it is based on scientific approach to only controlling those NPS that cause harm, rather than introducing a blanket ban on all NPS. Under the generic approach to risk assessment, groups of substances may be banned as a consequence, and there might be some unintended effects such as prohibition of substances which may not cause a high concern. As the EU decision to submit substance to criminal law control measures or to introduce EU-wide permanent market restriction measures would apply across the whole of the EU it may produce displacement effects towards third countries. In addition, these control measures may lead onto increased criminalisation of people, increase of the black market or decrease of the quality of the substances. (+) (-) Final Report 166

173 Practicability / feasibility Acceptability Overall, the preferred option has a medium to high practicability / feasibility. Very few of the elements could be considered to have low feasibility; only the introduction of the generic approach to risk assessment could be challenging to implement, as any restrictions or control measures may be difficult to justify without an individual risk assessment as only some Member States currently have a generic approach in their national systems; also the standardised tools and databases for risk assessments may prove costly to implement, which could impact negatively on feasibility / practicability. The practicability of increasing education and awareness-raising activities is very good, but its feasibility will depend on the extent to which financial resources can be allocated to the initiatives, both at EU and national level. It may also be challenging to develop an EU-wide harmonised approach to prevention, considering the different national views on new psychoactive substances and drugs in general, ranging from fairly liberal to very restrictive. There may be some (minor) difficulties in creating common definitions if Member States have trouble in reaching consensus. Nonetheless, the preferred option is largely highly practicable / feasible, firstly, because stakeholders have already expressed support for / advocated for many of the elements of option, such as the extension of the risk assessment period during temporary restriction (which stakeholders argues will increase the scientific credibility of EU risk assessments) and the EU reference list on harms associated with licit and illicit psychoactive substances, which will have an impact on better understanding of the types of ham and their impact. Other elements such as coordination and referral between the relevant EU instruments and conditions for Joint Reports - already exist and will merely be improved under the preferred option. Similarly, the toxic screen already exists, but would be moved to the earlier stages (Joint Report) stage of assessment, and risk assessment would be extended into the temporary measure phase. The remaining elements e.g. the common criteria and guidelines for proactive monitoring and the emergency procedure for developing Joint Reports would also be relatively easy to implement as they would only require the development of additional guidelines and procedures. In practice the introduction of temporary market emergency measure and permanent market restriction should also be feasible as, to an extent, Member States already control NPS through other means than criminal control, e.g. through medicines legislation to exert market restriction on the substance. The preferred option would have overall medium to high acceptability. In general, Member States are in favour of many aspects of the preferred option, such as developing common definitions, developing an EU reference list on harms associated with licit and illicit psychoactive substances, introducing additional standardised tools and databases for risk assessments and the generic approach to risk assessment (as Member States support the need to address specific groups of substances and as some have generic approaches in place). Member States are also likely to welcome the introduction of an emergency procedure which would help to confirm, within a short time period, whether a certain NPS would be particularly harmful and require urgent action, as well as control of NPS through permanent market restriction measure as opposed to criminal control only. Member States will be less in favour of certain aspects of the preferred option, such as including an early toxic screen in the Joint Report if national laboratories would have to undertake such screening. Although, overall, the positively received aspects of the preferred option would outweigh this, and political acceptability would be good if the EU would carry most of the costs. The improvement of coordination between EU instruments will be very acceptable to EU agencies; indeed, several EU stakeholders have already expressed the view that interaction between the different EU instruments, or scientific committees should be reinforced. Political acceptability at both EU and national level - of the creation/improvement of networks of research facilities and forensic laboratories is likely to be good, as there is a clear added value of structural collaboration between research institutes, forensic (++) (++) Final Report 167

174 Total laboratories and the EMCDDA, rather than individual approaches. It is also preferable over a central function as it would make use of existing expertise which would also continue to undertake national activities. The function is central to improving the knowledge and capacity of the EU system as regards risk management, but also possibly in relation to proactive monitoring and wider ongoing research. The public acceptability of the EU decision to introduce temporary emergency measures measure will be high, as this measure would reduce the availability of harmful substances/products in the market. In addition, the political acceptability is also likely to be relatively high, aside from implementation costs and some reservations on risk of other 'legitimate businesses' suffering as a consequence. However, industries distributing these substances may find the preferred option less acceptable as they will have reservations on temporary measures and EU-wide permanent market restriction measures; as well as the generic approach, as these measures may be considered disproportionate by industry, given that they risk restricting the sale of substances, which are not actually harmful. Nonetheless, stakeholders have indicated that they would welcome greater risk assessment and hence, measures to improve the procedure of risk assessment may be welcomed by industry. Medium practicability / feasibility / acceptability Final Report 168

175 Monetisation of impacts on costs and avoidance of harm The main types of costs regarding the preferred policy option include: Direct costs to Member State budgets these relate to the costs regarding the setup and running costs of implementing the preferred policy option in the EU Member States, including administrative costs of the monitoring and reporting that needs to be undertaken as part of the preferred option as well as training costs associated with the effective implementation of the option. Direct costs to EU budget these relate to the costs regarding the set-up and running costs that occur to the EU budget as a result of the preferred policy option. This also includes administrative costs of monitoring and reporting, as well as training costs. Indirect costs these include the costs of law enforcement and justice system to the public sector and costs incurred by industry as a result of the implementation of the preferred option Annex 8 sets out detailed cost estimates for each individual proposal included within the preferred option as well as the total cost of the preferred policy option. Overall, the approximate order of magnitude of the potential costs that are estimated to be incurred as a result of adopting the preferred policy option is approximately 46 million per annum, including the set-up costs. The annual costs after absorbing the set-up costs are estimated to be approximately 42million per annum. Table 7.3 summarises the overall estimated direct annual and one-off costs accruing to the EU and national governments as well as the indirect cost consequences for industry and for the public sector as a result of law enforcement and the justice system costs. Overall, indirect costs make up of a vast majority of the total costs of the preferred option (ca. 80%), with law enforcement costs consisting of just under half of all the costs and indirect costs to industry are amounting to approximately a fifth of the total costs associated with the preferred policy option. It has been estimated that each NPS subjected to a restriction or a control measure would lead to about 1% reduction in the overall market value of the NPS (ca. 500 million). This is because, although the banned substance is likely to have a substantial market share, new NPS are likely to emerge in the market rapidly, reducing the overall negative effects on the market value and revenue. Some smaller operators may be more severely impacted, especially if they had been specialising on a particular NPS subjected to control. Table 7.3 Overview of the overall costs of the preferred policy option The Preferred Policy Option Total cost % of total cost Direct cost to MS Direct cost EU Set up 1,284, % Running 3,208, % Admin 257, % Other , % Total 5,055, % Set up 2,345, % Running 1,962, % Admin 101, % Total 4,409, % 244 Other costs primarily refer to costs of research institutes investment to adapting their working processes to become part of the network of the structural collaboration between research institutes, forensic laboratories and the EMCDDA. Final Report 169

176 The Preferred Policy Option Total cost % of total cost Indirect costs Law enforcement 21,464, % Justice system 2,664, % Industry 12,500, % Total 36,629, % Overall total cost 46,094, % Overall total cost (excluding set-up costs) 42,463, % The overall cost structure of the preferred policy option is indicated in table 7.4 below. It shows, for each of its components, the proportion it represents of the total costs associated with the preferred policy option. The highest total costs are associated with the EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures, EU decision to introduce temporary emergency measures, educational and awareness-raising activities as well as structural collaboration between research institutes, forensic laboratories and the EMCDDA. With respect to the type of main stakeholders, the highest direct costs to Member States budgets relate to the EU decision to introduce temporary emergency measures and the EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures as well as costs relating to education and awareness raising activities. The highest costs to EU budget on the other hand relate to facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA and the educational and awareness-raising activities. The indirect costs are only associated with the EU Decision to introduce temporary emergency measures and the EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures, which incur as a consequence of the costs to the criminal justice system and market operators. Table 7.4 Overview of the cost structure of the preferred policy option Policy option % of total cost Total Direct cost (MS) Total Direct cost (EU) % % % Total Indirect cost 1.1 Establishment of EU reference list of harms 0.5% 0.8% 3.8% 0.0% 2.1 Introduction of common definitions 0.2% 1.3% 0.2% 0.0% 2.2 Improved coordination and referral to other EU legislation / mechanisms 0.05% 0.0% 0.5% 0.0% 3.3 Joint Report to include early toxic screen 0.0% 0.0% 0.0% 0.0% 3.4 Improved conditions for Joint Reports: Decision powers regarding Joint Reports 0.0% 0.0% 0.0% 0.0% 4.2 Development of common criteria and guidelines for proactive monitoring 0.4% 0.5% 3.5% 0.0% 4.5 Introduce additional standardised tools and databases for risk assessments 1.1% 3.0% 8.2% 0.0% Final Report 170

177 Policy option % of total cost Total Direct cost (MS) Total Direct cost (EU) % % % Total Indirect cost 4.6 Facilitating structural collaboration between research institutes, forensic laboratories and the EMCDDA 4.6% 5.3% 41.9% 0.0% 5.1 Generic approach by group of substances 0.1% 0.0% 1.4% 0.0% 6.1 Urgency Joint Report procedure for toxic substances 0.01% 0.0% 0.1% 0.0% 6.3 EU decision to introduce temporary emergency measures 33.9% 39.5% 4.5% 36.7% 6.4 Extending of Risk Assessment period during temporary restriction 0.0% 0.0% 0.0% 0.0% 7.2 EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures 53.0% 22.8% 2.5% 63.3% 8.1 Educational and awareness-raising activities 6.1% 26.7% 33.4%% 0.0% Total 100% 100% 100% 100% The preferred policy option will also have an impact on reducing the harms associated with the misuse of NPS. As was explained in section 3.2.4, the total value of harm was estimated at 211 million per annum. Although any reduction in harm must be approached with extreme caution, it has been estimated that the preferred policy option would remove about a quarter of the harms associated with NPS, accordingly valued approximately at 53 million. The harms are reduced in particular as a consequence of the following effects: Temporary emergency measure allows for an immediate reaction, which is particularly beneficial should the NPS be highly harmful, avoiding immediate harms. The temporary restriction would effectively allow remove a suspect harmful NPS from the market until the full risks have been identified. This will have an impact on the reduction of potential adverse health consequences through immediate consumer protection, without as heavy adverse consequences that may incur from criminal control EU decision to submit substances to criminal law control measures or to introduce EUwide permanent market restriction measures has the potential to reduce harms, particularly relating to those NPS that are considered highly harmful for consumers. In particular, market restriction allows for quicker permanent control of harmful NPS than what would be possible under criminal control. This provides effective response that has the impact on reducing adverse health consequences. The criminal control being introduced alongside the permanent market restriction may also act as a necessary deterrent, although it is also likely to bring perverse effects such as substance possibly being moved to be traded in the black market. Overall, the option provides a useful combination of control measures that have some effect on reducing harms Education and awareness raising activities are considered to have an important impact on harm reduction. This is particularly the case for NPS as insufficient and inaccurate information is currently available regarding their harmful effects. Accurate information is likely to have an impact on behavioural change in the consumption patterns, or at least young people are able to make better educated decisions on consuming such substances. These are likely to have an impact on reducing harmful health effects, particularly those relating to toxicity and accidental overdose leading to severe health effects. Final Report 171

178 The overall synergies of the preferred policy option contribute to the reduction in harms as the components reinforce each other s effects. The total estimated annual impact on harm avoided ( 53million) and the associated annual costs ( 46 million) of the preferred option are attributed to legislative and non-legislative proposals as follows: for non-legislative proposals in the preferred option: estimated approximate annual impact on hams avoided = 37million; estimated approximate annual impact on costs = 40 million; and for legislative proposals in the preferred option: estimated approximate annual impact on hams avoided = 16 million; estimated approximate annual impact on costs = 6 million. Overall, the benefits, i.e. the harm reduction, expected to be generated by the preferred policy option (about a quarter of the harms associated with the misuse of NPS) justifies the overall economic costs of the preferred option Intervention logic of the preferred policy option This section describes the intervention logic of the preferred policy option. (i) The main problems It is expected that the preferred policy option will addresses all the main problems that have been identified as part of this study, principally relating to the following three areas: Problems related to the market dynamics and use of new psychoactive substances Problems related to the differences in national approaches to new psychoactive Problems linked to the Council Decision and related drivers In relation to market dynamics and use of NPS, the preferred policy option will address use in a number of ways: (i) by increasing education and knowledge regarding NPS and increasing awareness of harms amongst users; (ii) by introducing the possibility of EU temporary measures and permanent market restrictions. The preferred option which introduces a generic approach to risk assessment - will also go some way to addressing the problem of the constant sharp rises in new substances and the displacement effects which are to some extent driven by the individual approach to risk assessments and control, as it will encourage Member States to introduce control measures that take a generic approach (and which will be less likely to allow new substances to quickly replace those which are chemically similar to those which come under control). Nonetheless, it is likely that industry will continue to develop NPS that may still be sold legally, so the preferred option can only have some impact on addressing problems related to market dynamics and use of NPS. In relation to differences between Member State approaches, the preferred option will have some effect on harmonisation: for example, it introduces a reference list of harms which will improve consistency between Member States classification of harm and it also introduces common definitions, which will make it easier for Member States to exchange information and compare their situations and information on harm and usage. In addition, a network of laboratories and research institutes will be created, which will have an impact on improving coordination and cooperation between Member States in addressing NPS through better knowledge regarding the effects of NPS. Finally, as some of the provisions of the preferred option (EU decision to introduce temporary emergency measures and EU decision to submit substance to criminal law control measures or to introduce EUwide permanent market restriction measures) increase harmonisation between Member States as EU decisions must be implemented in all Member States. Final Report 172

179 The preferred option also introduces a number of major changes which will address issues associated with the functioning of the Council Decision. First, the preferred option specifically addresses the fact that the current instrument is undermined by a lack of information / research on substances and consumption patterns, combined with the need to act fast. The preferred option introduces an urgency Joint Report procedure for toxic substances which will increase the speed with which the Commission may act. In addition, the introduction of additional standardised tools and databases for risk assessments will lead to increased information / research on substances and consumption patterns The instrument introduces new options for dealing with NPS, including temporary emergency measures and extended risk assessment periods which mean that the instrument will no longer only have a black & white outcome. However, in practice, it is unlikely that the temporary measures will lead to the legalisation of an NPS, meaning that (again in practice) the measures are unlikely to lead to anything other than control measures. (ii) Rationale The overall rationale for the proposed action at EU level, to address the problems and shortcoming identified, would include the following: Reduce, and to an extent, prevent the economic, health and social costs generated by harmful NPS Increase the research and scientific capacity to better understand the pharmacology and toxicology of NPS, as well as the related adverse health effects, in order to effectively respond to harmful NPS Better account for, and regulate the market dynamics in order to provide a measured response corresponding to the level of identified risk of harm or specific identified harm Avoid and reduce the unintended effects caused by disjointed action at EU level, through eliminating regulatory grey zones between EU regulatory instruments and adjusting for joint action at Member States level for substances that cause EU-wide concern. (iii) Objectives of the intervention The overall objective of EU action would be to strengthen the EU-wide response to NPS, reduce the harmful effects relating to misuse of NPS and improve the scientific knowledge and capability to better understand the health and social effects of NPS. The specific objectives would focus on improving: the overall knowledge of NPS, including the prevalence and reasons of use among different user groups the capacity to rapidly identify and assess harmful new psychoactive substances, and withdraw them from the market if necessary the consistency between national responses to harmful new psychoactive substances that are a cross-border problem the EU capability to respond to harmful substance including, providing a wider variety of possible measures to control NPS the response time to address harmful NPS and eliminating gaps between EU regulatory instruments that could be used to address NPS (iv) Content of EU action The preferred policy option would lead to the creation of a legislative instrument based on Article 114(3), Article 168(1) and Article 83(1) of TFEU. For further reference please refer to section 3.7 on right to act and subsidiarity. (v) Inputs required At EU level some relatively minor inputs would be required for the set-up and implementation of the relevant mechanisms. The main inputs would in particular relate to educational and awareness-raising activities, development of standardised tools and databases for risk Final Report 173

180 assessments, the establishment of EU reference list on harms associated with psychoactive substances and the development of common criteria and guidelines for proactive monitoring. Inputs would also be required for the overall development of the legislative proposal for the preferred policy option. The follow-up inputs would concern the monitoring and evaluation of its implementation. At the national level, inputs would be required for the set-up and implementation of the relevant mechanisms in all the Member States. The main inputs would primarily relate to the restriction and control measures, namely the obligations stemming from the EU decision to introduce temporary emergency measures and the EU decision to submit substances to criminal law control measures or to introduce EU-wide permanent market restriction measures. In addition, considerable inputs would be required for the educational and awareness-raising activities. Inputs would also be needed with respect to transposition and implementation of the legislative instrument. No specific set-up or implementation inputs would be required from the industry. (vi) The anticipated effects of EU action It is expected that, ultimately, the preferred policy option would have numerous benefits with respect to improving the overall knowledge of the chemical composition and harmful effects of NPS and consequently the capacity to rapidly withdraw harmful NPS from the market when necessary. The preferred policy option would also have the benefit of increasing consistency in response to harmful NPS, both in terms of coordinated national response as well as in terms of joined-up approach within the overall EU regulatory framework. The minor negative consequences relate to the potential perverse effects that result from controlling NPS, such as moving controlled NPS to be traded in the criminal market and criminalising a group of young people that choose to use these substances alongside other illicit drugs Considerations on monitoring and evaluation Monitoring and evaluating of the impact of the preferred policy option on an on-going basis is an important element for assessing the extent to which the policy option and its constituent parts is having the desired impact on the policy objectives and the reduction of harm caused by NPS. Table 7.5 outlines the proposed monitoring indicators and methods for monitoring and evaluation that should be instigated in order to assess the extent to which the preferred policy option is improving the identification and control of NPS and consequently reducing the potential harms caused by NPS. The focus is on evaluating the impact of the option on the six policy objectives described in Section 4 of this report: To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful new psychoactive substances To better account for, and where possible, regulate the market dynamics of new psychoactive substances To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the economic, health and social costs generated by harmful new psychoactive substances To better account for, and where possible, regulate the market dynamics of new psychoactive substances To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To eliminate regulatory grey zones between EU instruments and increase synergies Final Report 174

181 Table 7.5 also details the further refined specific policy objectives 245 that sit within the above specific objectives and the measures for monitoring progress. Table 7.5 Overview of the main monitoring indicators Specific policy objectives Further refined policy objectives Monitoring indicators Sources of data and evidence To improve and increase the (scientific) capacity of the current mechanism to efficiently and effectively anticipate, tackle and respond to harmful new psychoactive substances To improve the capacity to rapidly identify and assess harmful new psychoactive substances, and withdraw them from the market if necessary. Information on new psychoactive substances notified (number of notifications; characteristics of substance; Member State that notified; availability on the internet) o o o o Joint Reports Risk Assessments EDND EWS implementation reports (and the Reporting mechanisms of the Reitox NFPs and Europol ENUs) To better account for, and where possible, regulate the market dynamics of new psychoactive substances To improve the capacity to rapidly identify and assess harmful new psychoactive substances, and withdraw them from the market if necessary. Information on use and the characteristics and behaviour of users Information on sales (items sold) and profits of industry. Assessment of the market situation (most popular items etc) o o o o National surveys of users Surveys and other data collection tools developed for better informing EU risks assessments (under the preferred policy option) Mystery shopping Internet snapshots Information on NPS placed under market restrictions in Member States (to assess the extent to which EU/MS have introduced market regulations) To prevent and/ or reduce the potential risks to health of harmful new psychoactive substances To reduce the availability of harmful new psychoactive substances and their negative consequences on consumers' health and safety, and on society. Information on NPS put under control at EU and national level (implementing an EU instrument or following national procedures) o o o o Hospital admissions information Toxicology reports NGOs who work with NPS users Reitox NFPs Information on health alerts issued o Scientific literature 245 These specific objectives are those that Commission introduced as part of their preliminary Impact Assessment report and hence they have been mapped against the original specific objectives as defined as part of this study Final Report 175

182 Specific policy objectives Further refined policy objectives Monitoring indicators Sources of data and evidence (including information on notified and documented health adverse effects of new psychoactive substances) and follow-up given by responsible authorities To reduce the economic, health and social costs generated by harmful new psychoactive substances To reduce the availability of harmful new psychoactive substances and their negative consequences on consumers' health and safety, and on society. As above, plus: Information on the costs of healthcare provided to NPS users admitted to hospital after consuming NPS Information on any criminal activity and other anti-social behaviour associated with NPS use (e.g. involvement of OCG or anti-social behaviour of users). o o o Police and law enforcement data NGOs who work with NPS users Annual Reports of healthcare professionals and organisations To avoid and/ or reduce unintended effects caused by differences in approaches to new psychoactive substances between Member States To improve consistency between national responses to harmful new psychoactive substances that are a cross-border problem. To reduce the risk of displacement of harmful new psychoactive between the Member States. Information on the origin of imports and final destination of exports of NPS Mapping of the emergence of different NPS in all Member States o o o o Customs officials Notification of NPS to EWS EDND Annual Implementation Reports of Council Decision 2005/387/JHA To eliminate regulatory grey zones between EU instruments and increase synergies N/A Information on the synergies and overlaps with other EU mechanisms o Annual Implementation Reports of Council Decision 2005/387/JHA (especially the section which feeds back on synergies with EMA) N/A To avoid that Information on potential o Academic literature Final Report 176

183 Specific policy objectives Further refined policy objectives Monitoring indicators Sources of data and evidence restriction measures on substances impede future legitimate uses of these substances. legitimate uses of substances that may be classed as NPS o Reports of the EU network of laboratories and research institutes which will be developed as part of the preferred option It is recommended that EMCDDA, Europol and the network of research institutes established as part of the preferred option would be best placed to gather the data required in the most economical and efficient manner. It is recommended that the indicators are collected on an annual basis and reporting takes place annually as part of EMCDDA s and Europol s regular annual reporting processes. In addition, it is recommended that the Commission will evaluate the implementation, functioning, effectiveness, efficiency, utility and added value of the future mechanism on a regular basis. The evaluation should also include an assessment of the effectiveness of the restrictive measures introduced on the basis of the instrument. The Commission should commission an external evaluation of the instrument every five years, submit the result to the European Parliament and the Council, and propose amendments, if necessary This final paragraph has been taken exactly from section 7 of Commission s draft IAR of Final Report 177

184 Annex 1 Mapping of related safety mechanisms in the EU Substance / product Main monitoring instrument Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS Emerging psychoactive substances ( legal highs ) Early Warning System Council Decision 2005/387/JHA To monitor and exchange information on new psychoactive substances identified in the EU. Where there is evidence of harm, criminal involvements and/or extensive use, to conduct risk assessment. Where necessary introduce control measures. Non-controlled psychoactive substances (i.e. those not currently listed in the 1961 UN Convention on Narcotic and 1971 Convention on Psychotropic Substances), End-products, as distinct from precursors. National units identify and monitor emerging substances through various national information sources (e.g. drugs authorities, medical centres, law enforcement authorities, the media) and report information to a centralised database (EWS); The information is fed back to Member States; If the information reported reaches a certain threshold, a risk assessment of the substance is carried out at EU level; On the basis of this assessment the Commission decide whether or not to propose control measures; The whole process from identification to control takes around of 6-12 months. N/A Medicines Eudravigilance pharmacovigilance system (European Medicines Agency) Monitors the potential adverse effects of medicinal products. Monitors misuse / abuse of medicines e.g. for non-medical purposes. Substance(s) either presented as a medicine or used for (supposed) medicinal properties 247 Companies operating in the EU either register their products centrally with the EU, or with national authorities (and hence the product will be recognised in other EU countries through the Mutual Recognition Regulation). If registered centrally, the company must show proof of quality, safety and efficacy and they There is an established relationship between the Pharmacovigilance system and the EWS 247 Article 1(1) of Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use states that the scope of the Directive covers a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings ; or, b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis". Final Report 178

185 Substance / product Main monitoring instrument Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS will then receive marketing authorisation Member States and any company with authorisation to market a medicinal product is required to monitor any Adverse Reactions to the product Under the new rules produced for the Pharmacovigilance system, (which will come into operation in 2012), general medical practitioners and patients can also report adverse reactions via an online form The EMA also lists and makes public the status of all medicines authorised in the EU (i.e. whether they are authorised, suspended, withdrawn NPS are rarely marketed as medicines (although they may be marketed as herbal medicines see row below) so it is unlikely that the Pharmacovigilanc e system would pick up on NPS Final Report 179

186 Substance / product Herbal medicines Food Main monitoring instrument Committee for Herbal Medicinal Products (HMPC - part of the EMA) Directive 2004/24/EC (Herbal Directive) European Food Safety Authority s Rapid Alert System for Food and Feed (RAS-FF) Regulation 178/2002/EC Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS Ensures the registration and marketing authorisation of herbal medicinal products sold in the EU Places such products under scope of Pharmacovigilance system (see above) Coordinates risk assessments and identifies emerging risks; Provides scientific and technical advice to the Commission Traditional herbal medicinal Distributors apply to register a products 248 traditional herbal medicinal product with the EMA s centralised database Any substance (natural or synthetic) intended to be, or reasonably expected to be ingested orally They must provide documentation that the product in question is not harmful when used and proof of the 30 year track record The HMPC is responsible for drafting monographs for traditional herbal medicinal products, and lists of safe herbal substances Member States exchange information and introduce alerts through the RAS (Rapid Alert System), which is managed by the Commission (Article 50) When it is clear that a food or feed may pose serious risks to human health, the Commission can adopt emergency NPSs marketed as herbal medicines but not registered with the system may be taken off the market under this system Because NPS are ingested orally they are liable for control and monitoring under this mechanism. There is opportunity for establishing further official links with this 248 This means substances that: exclusively contain one or more herbal substances / preparations as active ingredients, where herbal substances are mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh, [or] certain exudates that have not been subjected to a specific treatment [but] are also considered to be herbal substances ; have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment; are exclusively for administration in accordance with a specified strength and posology; are an oral, external and/or inhalation preparation; have been used safely for at least 30 years (at least 15 years in EU) and have been proven not to be harmful have sufficient data on their traditional use and- in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible Final Report 180

187 Substance / product Main monitoring instrument Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS Collects and publishes scientific and technical data in areas relating to food safety; Introduces measures aimed at restricting the placing in circulation or withdrawal of food or feed from the market and the rejection of a batch or consignment of food or feed by an EU border post measures following a comitology procedure, or in extreme cases can adopt emergency measures on its own, to be confirmed by the Committee within ten days. These measures include withdrawal from the market, laying down of special conditions, or any appropriate interim measures. In addition, Directive 2000/13/EC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs - prohibits misleading labelling, presentation and advertising of foods. Controls are implemented by national authorities, which also impose sanctions. mechanism Food Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods Provides for the procedure to follow in order to ban, limit or subject to scrutiny substances other than vitamins or minerals that represent a potential risk to consumers Foods, including food supplements, to which substances other than vitamins or minerals have been added. Where a Member State has serious grounds for considering that a product endangers human health despite complying with this Regulation, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. A Member State or the Commission on its own initiative may request initiation of the procedure under article 8 of the Regulation in order to prohibit, restrict or place under scrutiny a substance other than a vitamin or mineral if a potential risk to consumers has been associated with its intake. Relevance dependent on NPS being marketed as food Food supplements Directive 2002/45/EC on the To ensure that food supplements are safe Food supplements marketed as foodstuffs Where a Member State, as a result of new information or of a re-assessment of existing Relevance dependent on Final Report 181

188 Substance / product Main monitoring instrument Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS approximation of laws of the Member States relating to food supplements and appropriately labelled so that consumers can make informed choices and presented as such Harmonises in detail the composition of food supplements only with respect to vitamins and minerals. The use of the substances other than vitamins and minerals in food supplements is governed by national rules and without prejudice to the provisions of the Treaty information has detailed grounds for establishing that a product endangers human health through it complies with the Directive, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission and give reasons for its decision. NPS being marketed as food supplements Chemicals Chemical safety mechanism (REACH) European Chemicals Agency (ECHA) protection of human health and the environment promotion of alternative methods for assessment of hazards of substances, facilitate the free circulation of substances on the internal market while enhancing competitiveness and innovation Chemical substances or mixture/solutions of two or more substances (preparations) i.e. chemical element in natural or in compound, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition Requires all manufacturers and importers of chemicals to identify and manage risks linked to the substances they manufacture and market. Manufacturers and importers must provide their downstream users with the risk information For substances produced or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately identified and managed risks linked to the substances by registering the proof with ECHA. ECHA is checks compliance with the REACH Regulation Where appropriate, authorities may also select substances for a broader substance Substances produced or imported in quantities of 1 tonne or more per year per company may be subject to further investigation i.e. evidence of risk to health Their risk assessment is carried out inhouse by ECHA However, the risk assessment does not cover misuse of the product (i.e. Final Report 182

189 Substance / product Main monitoring instrument Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS evaluation to further investigate substances of concern. ECHA carries out the assessment of the hazard and risk of substances on their own, in mixtures or articles, where it is considered that they pose a risk to human health or environment that is not adequately controlled and which needs to be addressed on an EU-wide basis. On this basis, and also taking into account the socio-economic consequences, a restriction report is prepared (either by Member States or by ECHA) and submitted for review to the Committee for Risk Assessment and the Committee for Socioeconomic Analysis in the European Chemicals Agency. Following the receipt of the Committee s opinion, the Commission decides under the comitology procedure whether to impose restrictions on the manufacture, use and sale either completely or under specific conditions where a product which has legitimate uses e.g. as a cleaning product but is consumed for its psychoactive properties Precursors Council Regulation 3677/90/EEC Regulation 273/2004/EC on drug precursors 249. To prevent the diversion of specific substances for use in the manufacture of narcotic drugs and psychotropic substances Precursors specifically listed in the Annexes to these documents Council Regulation 3677/90/EEC outlines provisions to be taken by Member States to prevent the diversion of these precursors, including: The regulation is only of relevance in cases where the precursors listed in these 249 Available from: Final Report 183

190 Substance / product Main monitoring instrument Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS documentation and labelling; notification to the EU of unusual orders and transactions of substances that may suggest they would be diverted for illicit manufacture prior notification of export of the listed substances to the Member State monitoring of export of listed substances which Member States have highlighted may be diverted within their territory for the illicit manufacture of psychoactive drugs. Regulation 273/2004 establishes harmonised measures for the control and monitoring, and the reporting on the sale and marketing, of certain substances frequently used for the illicit manufacture of narcotic drugs or psychotropic substances. documents It does not cover other precursors, including those which are biologically active and may be consumed as psychoactive substances in themselves (i.e. which are both a precursor and end-product) General product safety RAPEX Enables national authorities competent for product safety to: Introduce national restrictive measures; Any industrially manufactured product and any agricultural product, including fish products 250 When a product is found to be dangerous, the competent national authority takes appropriate action to eliminate the risk e.g. withdraw the product from the market, recall it from consumers or issue warnings. RAPEX would be a useful mechanism for the reporting of NPA; 250 Under Directive 2001/95/EC on general product safety, producers are obliged to place only safe products on the market. Article 3(2) states that, a product shall be deemed safe, as far as the aspects covered by the relevant national legislation are concerned, when, in the absence of specific Community provisions governing the safety of the product in question, it conforms to the specific rules of national law of the Member State in whose territory the product is marketed, such rules being drawn up... Article 3(3) states that the conformity of a product to the general safety requirement shall be assessed by taking into account the following elements in particular, where they exist: (a) voluntary national standards transposing relevant European standards; (b) the standards drawn up in the Member State in which the product is marketed; (c) Commission recommendations setting Final Report 184

191 Substance / product Main monitoring instrument Rationale / purpose Scope Process of mechanism Relevance for the monitoring / control of NPS Exchange information on risk assessment, dangerous products; Also allows the Commission to withdraw the product from the market for one year. Excludes food, pharmaceuticals and medicine RAPEX National Contact Points (which are often based in Ministries of commerce or industry, or in governmental or nongovernmental Consumer Protection Agencies) then inform RAPEX RAPEX disseminates the information that it receives to the National Contact Points of all other EU countries through weekly overviews of dangerous products and the measures taken to eliminate the risks on the internet. In exceptional cases of specific danger, the Commission can propose a temporary ban of the product for one year (renewable) where it is necessary to increase the length of the ban, REACH is used DG SANCO also has a specific agreement on information exchange with the General Administration of Quality Supervision, Inspection and Quarantine of China (AQSIQ). AQSIQ investigates all the notifications it receives from REACH and, when necessary, adopts measures to restrict further export of the notified dangerous consumer products to the EU. however, it relies on consumers believing that the psychoactive effects were an adverse reaction rather than the intended one. Moreover, it covers products which are not for consumption guidelines on product safety assessment; (d) product safety codes of good practice in force in the sector concerned; (e) the state of the art and technology; (f) reasonable consumer expectations concerning safety. Final Report 185

192 Annex 2 Relationship between Council Decision 2005/387/JHA and other EU mechanisms New psychoactive substance is detected in Member State The substance was not consumed specifically for its psychoactive properties (i.e. consumed by accident). The substance is marketed legitimately for another purpose, but is misused/abused for its psychoactive properties The substance is marketed for psychoactive properties, but under the guise of a legitimate product (e.g. bath salts, etc.) and (often) labelled not suitable for human consumption Substance is detected in a food product reported to the Rapid Alert System for Food and Feed (RAS-FF) Substance is marketed as a medicine / herbal medicine reported to the Eudravigilance system (EMA) Substance is marketed as a product - possibility of reporting to the Rapid Alert System for products (RAPEX) Member State reports the substance to the Early Warning System (EMCDDA) Member State proposes to control the substance, before the Commission has controlled it centrally Information is provided by the EMA More information on the marketing authorisation of the substance is needed More information on the possible medicinal uses of the substance is needed The EMCDDA decides to carry out a Joint Report Member State is required to notify the Commission of any proposed technical regulation which would prevent the marketing or sale of a product in their Member State, under Regulation 98/34/EC The substance has a medicinal uses / is used in the production of medicines The EMA has information More information on the medicinal uses / uses in the production of medicines is needed The substance is used as a precursor in other useful/legitimate GREY ZONE The Commission decides not to introduce control procedures The Commission discusses the possibility of restricting the product to its medicinal uses only and controlling for all other non-medical uses. The EMA does not have information available GREY ZONE The Commission decide to carry out a Risk Assessment The Commission decide to introduce control measures Two members of the EMA form part of the Scientific Committee who assess the need for control measures Final report 186

193 Annex 3 The role of international instruments in monitoring and regulating new psychoactive substances The Council Decision interrelates with international systems for monitoring and controlling new psychoactive substances. First, the Decision makes a number of explicit references to the United Nations system which in this context is comprised of the World Health Organisation (WHO) 251, the Commission on Narcotic Drugs (CND) 252 at the United Nations Office for Drugs and Crime (UNODC) 253, and/ or the Economic and Social Committee. Article 2 of the Council Decision 2005/387/JHA, which defines the scope of the instrument, stipulates that it applies to substances which are currently not listed under the schedules of the following two UN conventions: 1961 Single Convention on Narcotic Drugs 254 ; and 1971 Convention on Psychotropic Substances 255. The above conventions also outline the responsibilities of the WHO, the CND and the Economic and Social Committee which define the UN system in the context of new psychoactive substances as mentioned above. Article 5.2(e) of the Council Decision requires the Europol-EMCDDA Joint Report to include information on whether or not a new substance is currently under assessment, or has been under assessment by the UN system this information is obtained through communication channels with the Department of Medicines Policy and Standards. In the EMCDDA-Europol Annual Implementation Reports, it is regularly reported that cooperation and information exchange with this UN department is fully operational and the required information is obtained almost without a delay 256. The EMCDDA also formed part of the working group for the revision of the WHO Guidelines in 2006 for the review of dependence-producing psychoactive substances for international control. WHO (through the Department of Medicines Policy and Standards) also responds to EMCDDA questions on substances undergoing risk assessment. This was the case with BZP in The department also provided feedback during the preparation of the Guidelines for the risk assessment of new psychoactive substances. In 2010 when mephedrone underwent a risk assessment by the EMCDDA, WHO confirmed to the EMCDDA that mephedrone was not undergoing assessment in the UN system, so that the EMCDDA could ensure accordance with Article 5.2(e) of the Council Decision. Articles 6 and 7 of the Council Decision 2005/387/JHA show the interrelationship with the UN system with regard to the risk assessment of new psychoactive substances: Article 6 of the Decision states that the risk assessment report of the health and social risks caused by the use and/ or manufacture of and/ or traffic in a new psychoactive substance, in the involvement of organised crime and possible consequences of control measures should include information on any assessment of the substance in the United Nations system among others; Article 7 of the Decision states that no risk assessment will be carried out under the instrument in the instances when: the new psychoactive substance concerned is at an advanced stage of assessment within the United Nations system, namely once the WHO expert committee on drug dependence has published its critical review together with a written See e.g. EMCDDA-Europol 2006 Annual Implementation Report of Council Decision 2005/387/JHA Final report 187

194 recommendation, except where there is significant new information that is relevant in the framework of the Decision; the new psychoactive substance has been assessed within the United Nations system, but it has been decided not to schedule the new psychoactive substance under the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances. In addition, the Council Decision 2005/387/JHA refers to Resolution 46/7 Measures to promote the exchange of information on new patterns of drug use and on psychoactive substances consumed 257 of the CND, specifying that it provides a useful framework for action by the Member States. The framework requires Member States to do the following: Prepare a list of certified physical and/or juridical persons or laboratories capable of conducting analytical, toxicological, pharmacological and bio-psychological evaluations and who may be consulted in their national territory; Develop expertise in epidemiology for the purpose of collecting and evaluating cases involving abuse of and dependence on psychoactive substances; Involve the pharmaceutical industry and law enforcement in the expansion of knowledge about the potential for abuse of and dependence on psychoactive substances; Cooperate with other States in order to disseminate specialized information through international bodies. 258 The Resolution also invites the UNODC 259 and the WHO, provided that voluntary funds are available, to convene a meeting of experts to establish guidelines for the recording of cases of drug abuse and dependence. The long-term objective is to establish a worldwide databank and improve the assessment of the potential of abuse and dependence of psychoactive substances. UNODC was created in 1997, as a result of the fusion between the United Nations Drug Control Programme and the Centre for International Crime Prevention. Its mandate covers international crimes and the fight against illicit drugs. UNODC focus on (a) drug use prevention, treatment and care (i.e. drug prevention as health issue rather than a criminal issue); and (b) the issue of drug trafficking (i.e. the criminal issue). With regard to data collection and analysis in the field of drug policies, the UNODC yearly produces the World Drug Report, which aims to provide comprehensive information on the illicit drug situation as well as detailed estimates and trends. The UNODC World Drug Report outlines the trends of emerging psychoactive substances as well. It also gives information on possible drivers to these trends: to evade an established law enforcement pattern; because they are not nationally or internationally regulated and controlled; to replace substances whose supply is decreasing; and to satisfy the evolving requirements of users. At the WHO, the Expert Committee on Drug Dependence (ECDD) carries out medical and scientific evaluations of the potential for abuse of drugs falling within the terms of the 1961 and 1971 Conventions mentioned above. The Expert Committee are also responsible for making decisions on whether or not to include emerging substances to the two Conventions through publication of a critical review together with a written recommendation. The procedure for psychoactive substance evaluation is described in detail in the Guidelines for the WHO review of psychoactive substances for international control 261. The EMCDDA consults regularly with the ECDD and other bodies in the UN system in its assessment of drugs reported to the EWS Final report 188

195 In addition to its interplay with the UN system, the Council Decision 2005/387/JHA interacts with the Council of Europe system as well, particularly within the Pompidou Group 262. Also referred to as the Cooperation Group to combat drug abuse and illicit trafficking in drugs, the Pompidou Group is an inter-governmental body which was established in 1971 and was originally composed of seven Member states: Belgium, France, Germany, Italy, Luxembourg, Netherlands, and the United Kingdom. The Group now gathers 35 Member States 263 as well as representatives from the European Commission and its main activities include an Ad hoc Expert Group on the Prevention of Drug Precursors Diversion and research on specific issues determined by the Pompidou Work Programme Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, San Marino, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, former Yugoslav republic of Macedonia and Turkey. Final report 189

196 Annex 4 Individual health risks of new psychoactive substances Type of substance GHB Precursor:G BL Acute effects Clinical effects: Dependence Psychological effects Nausea, vomiting, hypotonia, bradycardia, hypothermia, random clonic movements, coma, respiratory depression and apnoea. Reported subjective effects of GHB use include: euphoria, hallucinations, relaxation and disinhibition. Deaths involving solely GHB appear to be rare. The majority of these cases have involved the recreational abuse of GHB for its subjective euphoric ( high ) effects, primarily by young adults. The mode of GHB abuse frequently involves the use of other drugs such as alcohol or MDMA. There have been few studies regarding the dependence potential of GHB. However, during studies involving administration of GHB to patients at varying concentrations, no dependence has been observed at low doses of GHB. At prolonged high doses, however, physical dependence as evidenced by a withdrawal syndrome has been noted in some cases and included symptoms of insomnia, muscular cramping, tremor and anxiety The effects of GHB on the central nervous system have implications for the ability to drive and to operate machinery. Social consequences Clumsy behaviour, vomiting and loss of consciousness in dance settings are regarded unfavourably by music promoters, club owners and youth media journalists. A range of factors such as low price, ease of availability and administration, lack of information, the need for sedation following heavy stimulant use, and careless media coverage, increase the probability of GHB diffusion and consequent harm. Other factors, such as antisocial effects, relatively short duration, and its low-status image, mitigate against widespread diffusion and so decrease the probability of harm. BZP Vomiting, headache, palpitations, poor appetite, stomach pains/nausea, anxiety, insomnia, strange thoughts, mood swings, confusion, irritability and tremors. Agitation, tachycardia and seizures There have been very few instances of fatalities involving BZP. It appears that BZP could possess an abuse and dependence potential, but there are no clinical studies to support this. Psychological problems, such as trouble sleeping, loss of energy, strange thoughts, mood swings, confusion and irritability No clear evidence. This might indicate that BZP leads to very limited social harms. Spice Effects on the cardiovascular and nervous system: Tachycardia and, in some cases, short-term loss of consciousness. The possibility of accidental overdosing with a risk of Some emergency cases were reported in Germany and Italy The patients registered an excited state and in psychomotor agitation No alteration of vital parameters are usually registered. It seems that tolerance to these synthetic cannabinoids may develop fairly fast, and arguably this might be associated with relatively Biological and psychological effects described by users are due to the added synthetic cannabinoids, No experimental data. Final report 190

197 severe psychiatric complications cannot be excluded. In all cases, the presence of the synthetic cannabinoids was not confirmed by toxicological analysis. high potential to cause dependence. Further studies are needed. which are not reported on the label. This raises the possibility that there may be a deliberate marketing strategy to represent this product as natural. 2C-I, 2C-T-2 and 2C-T-7 There has been no other specific research conducted on these new substances. Some users report stomach tension, nausea, vomiting and jaw tension. Effects are typically described as lasting for up to 10 hours post oral dose. There have been no reported deaths or instances of non-fatal intoxication involving these substances. They produce various psychedelic effects (generally comparable to other hallucinogens) and feelings of empathy (similar to MDMA). Studies on similar compounds suggest that it is unlikely to produce physical dependence or addiction, but no specific research has been performed to evaluate their potential. No public data on this matter, but some introspection and negative thoughtloops were described by a number of users. There is currently no scientific evidence of negative social consequences. However, these substances carry potential risks common to other hallucinogenic substances. 4-MTA Serotonin syndrome: euphoria, drowsiness, sustained rapid eye movement, overreaction of the reflexes, rapid muscle contraction and relaxation in the ankle causing abnormal movements of the foot, clumsiness, restlessness, feeling drunk and dizzy, muscle contraction and relaxation in the jaw, sweating, intoxication, muscle twitching, rigidity, high body temperature, mental status changes shivering. Other effects: nausea, hyperthermia, thirst, shivering, confusion, memory loss, coma, and heart attack. Amnesic effects lasting several hours have been reported. Ten non-fatal overdoses, nine requiring hospitalisation, have been reported. 5 deaths in EU. There have been no systematic studies of dependence potential. 4- MTA has shown similar properties to MDMA Serotonin syndrome: Stronger and longer lasting effects than ecstasy and frequently more unpleasant effects than ecstasy. Peaceful and calm feeling, a stimulating effect, which is neither energizing nor psychedelic, but it strongly hampers sleep. The negative effects (such as: nausea, headaches and delayed effects) indicate a low likelihood that 4-MTA will grow in popularity, or become widely used. It is very unlikely that there are any significant harmful social consequences for the user that could be attributed specifically to the use of 4-MTA. Final report 191

198 Annex 5 Public health risks of new psychoactive substances Type of substa nce Availability and quality Knowledge and perception of GHB among users: Prevalence patterns of use and Characteristics and behaviour of users Indicators of health consequences GHB Preparations containing GHB have marketing authorisation in four countries: in Austria and Italy for alcoholic craving and in France and Germany as an anaesthetic. In dance settings, GHB is frequently sold in liquid form in small 3 ml plastic bottles containing approximately 3 g of GHB, where it is used socially for relaxation, mild euphoria or post-party for sleep. Pharmaceutical-grade GHB is also available through the Internet, catalogue sales and specialist shops in some countries. Although media reporting of GHB is limited, information is available to the populations who use recreational drugs, smart drugs or body-building drugs, via associated social networks. A vast number of Internet sites and newsgroups promote the use of GHB for a wide range of purposes which include: sleep, mood enhancement, treatment of drug and alcohol withdrawal, sexual enhancement, bodybuilding and anti-ageing. Anecdotal and Internet reports suggest that use of GHB may not be confined to recreational party drug settings. Internet postings and outreach workers suggest that GHB can also be used as a substitute for alcohol or drugs to achieve inebriation whilst avoiding detection tests in treatment, the workplace, and for driving. Drug users, recreational drug users or users attending electronic dance music events. The comparatively low price of GHB provides a cheap alternative to alcohol and when used for illicit purposes the effects of GHB are much closer to those produced by alcohol, cannabis and benzodiazepines, than they are to MDMA and other stimulant drugs. The physical incapacity and unconsciousness resulting from a relatively small increase in GHB doses demonstrates that health risks in relation to road traffic or operating machinery are high. GHB has been associated with 11 deaths in the EU between September 1995 and January 2000: four in the United Kingdom, four in Sweden, two in Finland, and one in Denmark. In addition, two deaths have been reported in Norway. Non-fatal hospital admissions associated with GHB are difficult to assess as GHB analysis is not routinely performed by hospital toxicology laboratories. However, there have been at least 200 reported GHB overdose cases in Europe (in particular in Sweden, the United Kingdom, the Netherlands, Denmark, Belgium, Finland, Spain and Norway). BZP BZP is sold as tablets and capsules, often via Internet sites, in smart shops and legal high stalls at festivals Spice Information on patterns of use was collected mostly through Internet forums, where users are sharing experiences. Spice products can be smoked, sometimes together with cannabis, or consumed orally as an infusion. Spain reported that users Users seem to be a heterogeneous group. They may include those wanting a legal alternative to illegal drugs, or drug users wishing to pass successfully an employment/other drug testing procedure aimed at detecting illicit drug use. Final report 192

199 Type of substa nce Availability and quality Knowledge and perception of GHB among users: Prevalence patterns of use and Characteristics and behaviour of users Indicators of health consequences recommend using pipes while Slovakia reports that the fumes of the burning mixture could be inhaled. 2C-I, 2C-T-2 and 2C- T-7 2C-I is very rare and it is probably not sold to users as ecstasy (MDMA). The level of awareness about 2C-I is generally negligible, except among small subgroups of experimenters who may use mescaline, DOB or 2C-B for particular effects. Evidence of 2C-I, 2C-T2 AND 2C-T-7 use in the EU is very limited. Very small group of people with a pseudo-scientific interest in experimenting with hallucinogenic substances often referred to as psychonauts. A few more experimental drug users appear to be motivated to use 2C-I or 2C-T-7 by a desire to experience a wide range of sensations. Limited information on the health and long term consequences. 4-MTA 4-MTA has been identified in six Member States and in Australia Knowledge of 4-MTA is low among users and tablets containing it are generally believed to be a particularly strong, and long-lasting, type of ecstasy It is believed to form only a very small proportion of the ecstasy market. Patterns of use are the same as for ecstasy. Young people aged between 16 and 30 with a more equal gender ratio No information on the long-term consequences of 4-MTA use is available. Final report 193

200 Annex 6 Nationality and background of respondents to the online national stakeholder survey There were 64 respondents (in total) to the national stakeholder survey. There was one respondent only from Austria, Denmark, Estonia, Lithuania, Portugal and Spain; two respondents from Cyprus, Germany, Ireland, Latvia, Malta, Poland, Romania, Slovak Republic and Sweden; and three from Belgium, Czech republic, Finland, Hungary, Italy, Luxembourg and the UK. Four stakeholders responded from Bulgaria, Greece and Slovenia. Final report 195

201 The majority of respondents were from the health sector (Ministry of Health or public health institute/agency), with the second-largest majority being from law enforcement (i.e. Ministries of Justice or other law enforcement agency). Final report 196